🔍 RecallPedia

Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 00810068567410 PRES0420CPKPLT 00810068567489 PRES0517CPKPLT 00810068567519 PRES0540CPKPLT 00810068568028 PRES0620CPKPLT 00810068567557 PRES0635CPKPLT 00810068567564 PRES0650CPKPLT 00810068567571 PRES0720CPKPLT 00810068567588 PRES0735CPKPLT 00810068567595 PRES0750CPKPLT 00810068567601 PRES0830CPKPLT 00810068567618 PRES0845CPKPLT 00810068567625 PRES0153HXPPL 00818053027147 PRES0204HXPPL 00818053029943 PRES0204CXPPL 00818053027321 PRES0208HXPPL 00818053029981 PRES0315HXPPL 00818053027178 PRES0307CXPPL 00818053027376 PRES0420HPKPL 00818053027185 PRES0440HPKPL 00810068567830 PRES0520HPKPL 00818053027192 PRES0540HPKPL 00810068567847 PRES0650HPKPL 00810068567854 PRES0720HPKPL 00818053027215 PRES0750HPKPL 00810068567861 PRES0830HPKPL 00818053027222 The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.

Class I - Dangerous
🏥 Medical Devices Recalled: May 8, 2025 BALT USA Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Product Description/Product Catalog Number/UDI-DI/Lot Numbers: PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800442 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800505 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800708 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800794 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800513 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800544 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800512 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800538 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800790 PRES1445CPKPLT Prestige 14mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1445CPKPLT 00810068567724 F230800793 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800574 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800575 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800576 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800947 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800549 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800759 PRES0258CXPPLT Prestige 2.5mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0258CXPPLT 00810068567380 F230800833 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800515 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800527 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800578 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800791 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800941 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800454 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800546 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800771 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800888 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800479 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800580 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800715 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800938 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F241100052 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800940 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800949 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800418 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800529 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800482 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800483 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800769 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800504 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800763 PRES0320CXPPLT Prestige 3mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0320CXPPLT 00810068567410 F230800441 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800795 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800796 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800451 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800664 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800797 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800831 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800822 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800886 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F241200132 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800458 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800517 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800511 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800519 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800766 PRES0650CPKPLT Prestige 6mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0650CPKPLT 00810068567571 F230800821 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800440 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800510 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800518 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800537 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800818 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230900021 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800444 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800509 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800665 PRES0830CPKPLT Prestige 8mm x 30cm (Ver. T) Prestige Plus Complex Pack PRES0830CPKPLT 00810068567618 F230800516 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800486 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800503 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800481 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800524 PRES0204HXPPL Prestige Coil 2mm x 4cm Prestige Plus Helical Xtra Pac PRES0204HXPPL 00818053029943 F230800782 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F230800809 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F240501011 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800863 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800864 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800865 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800879 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800880 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800815 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800890 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800892 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F241100535 PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0307CXPPL 00818053027376 F230800746 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800861 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800862 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900036 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900037 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900038 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F241100975 PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800889 PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800893 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800438 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800447 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800498 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800704 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800943 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F241200129 PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800445 PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800569 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800448 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800467 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800570 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800727 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800810 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F230800565 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501363 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501600 PRES0750HPKPL Prestige Coil 7mm x 50cm Prestige Plus Helical Pack PRES0750HPKPL 00810068567861 F230800891 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F230800860 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F240501413
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
BALT USA, LLC
Reason for Recall:
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694 PRES1445CPKPLT 00810068567724 PRES0103CXPPLT 00810068567304 PRES2512CXPPLT 00810068567397 PRES0258CXPPLT 00810068567380 PRES0212CXPPLT 00810068567373 PRES0204CXPPLT 00810068567342 PRES0206CXPPLT 00810068567359 PRES0208CXPPLT 00810068567366 PRES3520CXPPLT 00810068567441 PRES3530CXPPLT 00810068567458 PRES0310CXPPLT 00810068567403 PRES0320CXPPLT 00810068567410 PRES0420CPKPLT 00810068567489 PRES0517CPKPLT 00810068567519 PRES0540CPKPLT 00810068568028 PRES0620CPKPLT 00810068567557 PRES0635CPKPLT 00810068567564 PRES0650CPKPLT 00810068567571 PRES0720CPKPLT 00810068567588 PRES0735CPKPLT 00810068567595 PRES0750CPKPLT 00810068567601 PRES0830CPKPLT 00810068567618 PRES0845CPKPLT 00810068567625 PRES0153HXPPL 00818053027147 PRES0204HXPPL 00818053029943 PRES0204CXPPL 00818053027321 PRES0208HXPPL 00818053029981 PRES0315HXPPL 00818053027178 PRES0307CXPPL 00818053027376 PRES0420HPKPL 00818053027185 PRES0440HPKPL 00810068567830 PRES0520HPKPL 00818053027192 PRES0540HPKPL 00810068567847 PRES0650HPKPL 00810068567854 PRES0720HPKPL 00818053027215 PRES0750HPKPL 00810068567861 PRES0830HPKPL 00818053027222 The Prestige Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.

Product Codes/Lot Numbers:

Product Description/Product Catalog Number/UDI-DI/Lot Numbers: PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800442 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800505 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800708 PRES0153CXPPLT Prestige 1.5mm x 3cm (Ver T) Prestige Plus Complex Xtra Pk PRES0153CXPPLT 00810068567311 F230800794 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800513 PRES1045CPKPLT Prestige 10mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1045CPKPLT 00810068567663 F230800544 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800512 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800538 PRES1245CPKPLT Prestige 12mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1245CPKPLT 00810068567694 F230800790 PRES1445CPKPLT Prestige 14mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES1445CPKPLT 00810068567724 F230800793 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800574 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800575 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800576 PRES0103CXPPLT Prestige 1mm x 3cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0103CXPPLT 00810068567304 F230800947 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800549 PRES2512CXPPLT Prestige 2.5mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES2512CXPPLT 00810068567397 F230800759 PRES0258CXPPLT Prestige 2.5mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0258CXPPLT 00810068567380 F230800833 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800515 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800527 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800578 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800791 PRES0212CXPPLT Prestige 2mm x 12cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0212CXPPLT 00810068567373 F230800941 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800454 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800546 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800771 PRES0204CXPPLT Prestige 2mm x 4cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0204CXPPLT 00810068567342 F230800888 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800479 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800580 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800715 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F230800938 PRES0206CXPPLT Prestige 2mm x 6cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0206CXPPLT 00810068567359 F241100052 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800940 PRES0208CXPPLT Prestige 2mm x 8cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0208CXPPLT 00810068567366 F230800949 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800418 PRES3520CXPPLT Prestige 3.5mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3520CXPPLT 00810068567441 F230800529 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800482 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800483 PRES3530CXPPLT Prestige 3.5mm x 30cm (Ver. T) Prestige Plus Complex Xtra Pk PRES3530CXPPLT 00810068567458 F230800769 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800504 PRES0310CXPPLT Prestige 3mm x 10cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0310CXPPLT 00810068567403 F230800763 PRES0320CXPPLT Prestige 3mm x 20cm (Ver. T) Prestige Plus Complex Xtra Pk PRES0320CXPPLT 00810068567410 F230800441 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800795 PRES0420CPKPLT Prestige 4mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0420CPKPLT 00810068567489 F230800796 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800451 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800664 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800797 PRES0517CPKPLT Prestige 5mm x 17cm (Ver. T) Prestige Plus Complex Pack PRES0517CPKPLT 00810068567519 F230800831 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800822 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F230800886 PRES0540CPKPLT Prestige 5mm x 40cm (Ver. T) Prestige Plus Complex Pack PRES0540CPKPLT 00810068568028 F241200132 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800458 PRES0620CPKPLT Prestige 6mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0620CPKPLT 00810068567557 F230800517 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800511 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800519 PRES0635CPKPLT Prestige 6mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0635CPKPLT 00810068567564 F230800766 PRES0650CPKPLT Prestige 6mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0650CPKPLT 00810068567571 F230800821 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800440 PRES0720CPKPLT Prestige 7mm x 20cm (Ver. T) Prestige Plus Complex Pack PRES0720CPKPLT 00810068567588 F230800510 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800518 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800537 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230800818 PRES0735CPKPLT Prestige 7mm x 35cm (Ver. T) Prestige Plus Complex Pack PRES0735CPKPLT 00810068567595 F230900021 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800444 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800509 PRES0750CPKPLT Prestige 7mm x 50cm (Ver. T) Prestige Plus Complex Pack PRES0750CPKPLT 00810068567601 F230800665 PRES0830CPKPLT Prestige 8mm x 30cm (Ver. T) Prestige Plus Complex Pack PRES0830CPKPLT 00810068567618 F230800516 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800486 PRES0845CPKPLT Prestige 8mm x 45cm (Ver. T) Prestige Plus Complex Pack PRES0845CPKPLT 00810068567625 F230800503 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800481 PRES0153HXPPL Prestige Coil 1.5mm x 3cm Prestige Plus Helical Xtra Pac PRES0153HXPPL 00818053027147 F230800524 PRES0204HXPPL Prestige Coil 2mm x 4cm Prestige Plus Helical Xtra Pac PRES0204HXPPL 00818053029943 F230800782 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F230800809 PRES0204CXPPL Prestige Coil 2mm x 4cm Prestige Plus Complex Xtra Pac PRES0204CXPPL 00818053027321 F240501011 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800863 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800864 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800865 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800879 PRES0208HXPPL Prestige Coil 2mm x 8cm Prestige Plus Helical Xtra Pac PRES0208HXPPL 00818053029981 F230800880 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800815 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800890 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F230800892 PRES0315HXPPL Prestige Coil 3mm x 15cm Prestige Plus Helical Xtra Pac PRES0315HXPPL 00818053027178 F241100535 PRES0307CXPPL Prestige Coil 3mm x 7cm Prestige Plus Complex Xtra Pac PRES0307CXPPL 00818053027376 F230800746 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800861 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230800862 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900036 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900037 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F230900038 PRES0420HPKPL Prestige Coil 4mm x 20cm Prestige Plus Helical Pack PRES0420HPKPL 00818053027185 F241100975 PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800889 PRES0440HPKPL Prestige Coil 4mm x 40cm Prestige Plus Helical Pack PRES0440HPKPL 00810068567830 F230800893 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800438 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800447 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800498 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800704 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F230800943 PRES0520HPKPL Prestige Coil 5mm x 20cm Prestige Plus Helical Pack PRES0520HPKPL 00818053027192 F241200129 PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800445 PRES0540HPKPL Prestige Coil 5mm x 40cm Prestige Plus Helical Pack PRES0540HPKPL 00810068567847 F230800569 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800448 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800467 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800570 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800727 PRES0650HPKPL Prestige Coil 6mm x 50cm Prestige Plus Helical Pack PRES0650HPKPL 00810068567854 F230800810 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F230800565 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501363 PRES0720HPKPL Prestige Coil 7mm x 20cm Prestige Plus Helical Pack PRES0720HPKPL 00818053027215 F240501600 PRES0750HPKPL Prestige Coil 7mm x 50cm Prestige Plus Helical Pack PRES0750HPKPL 00810068567861 F230800891 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F230800860 PRES0830HPKPL Prestige Coil 8mm x 30cm Prestige Plus Helical Pack PRES0830HPKPL 00818053027222 F240501413

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1989-2025

Related Recalls

Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flexible distal shaft. The design facilitates the advancement of the Mega Ballast to access the tortuous vasculature over a guidewire and a respective dilator. The outer surface of the Mega Ballast is coated with a hydrophilic coating to facilitate lubricity from tip to 40 cm proximal. The proximal end of the Mega Ballast incorporates a Luer fitting hub for the attachment of accessories. The Mega Ballast is provided sterile, non-pyrogenic, and is intended for single use only. Component: Not a component

BALT USA

Class I - Dangerous

Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.

Sep 25, 2025 Infusion Pumps View Details →

Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875 OPTI0158BLK 00810068568882 OPTI0103BLK 00810068568851 OPTI0258BLK 00810068568929 OPTI0212BLK 00810068568912 OPTI0206BLK 00810068568905 OPTI0310BLK 00810068568943 OPTI0320BLK 00810068568950 OPTI0151HSS10 00818053026614 OPTI0152HSS10 00840303701002 OPTI0153HSS10 00840303701019 OPTI0154CSS10 00818053025761 OPTI0154HSS10 00840303701026 OPTI1027CST10 00840303700142 OPTI1030HST10 00818053027086 OPTI1034COM18 00818053026461 OPTI1137COM18 00818053026478 OPTI1550COM18 00818053026515 OPTI0101CSS10 00818053025709 OPTI0101HSS10 00840303700951 OPTI0102CSS10 00818053025716 OPTI0102HSS10 00840303700968 OPTI0103HSS10 00818053026591 OPTI0103CSS10 00818053025723 OPTI0104HSS10 00818053026607 OPTI0254CSS10 00840303700548 OPTI0255CSF10 00840303700203 OPTI0256CSS10 00818053025853 OPTI0256HSS10 00818053026737 OPTI0202HSS10 00840303701040 OPTI0203HSS10 00840303701057 OPTI0203CSS10 00818053025785 OPTI0204CSS10 00840303700494 OPTI0204HSS10 00840303701064 OPTI0206CSF10 00818053026027 OPTI0206CSS10 00818053025808 OPTI0208CSF10 00818053026034 OPTI0208HSS10 00840303701088 OPTI0208CSS10 00840303700517 OPTI0358CSS10 00818053025921 OPTI0310HSS10 00840303701156 OPTI0310CSS10 00818053025907 OPTI0310HSF10 00840303700814 OPTI0310CSF10 00840303700234 OPTI0304HSS10 00840303701125 OPTI0304HSF10 00840303700784 OPTI0304CSS10 00818053025877 OPTI0306HSS10 00840303701132 OPTI0308HSS10 00840303701149 OPTI0308CSF10 00818053026065 OPTI0308CSS10 00840303700593 OPTI0410CSS10 00840303700654 OPTI0410HSF10 00840303700852 OPTI0413CSF10 00818053026119 OPTI0406HSS10 00840303701163 OPTI0408HSS10 00818053026799 OPTI0413CST10 00840303700036 OPTI0510HSS10 00840303701217 OPTI0510CSS10 00840303700685 OPTI0510HSF10 00840303700890 OPTI0513CSS10 00840303700692 OPTI0517CSF10 00818053026157 OPTI0517CST10 00840303700050 OPTI0508CSS10 00840303700678 OPTI0509CSF10 00818053026140 OPTI0610HSF10 00840303700937 OPTI0611CSF10 00818053026171 OPTI0620CSF10 00840303700357 OPTI0620HST10 00840303700715 OPTI0713CST10 00840303700081 OPTI0713CSF10 00840303700364 OPTI0724CSF10 00818053026218 OPTI0724CST10 00840303700098 OPTI0724COM18 00818053026430 OPTI0827CSF10 00818053026232 OPTI0827CST10 00840303700111 OPTI0923CST10 00818053026379 OPTI0930COM18 00818053026454 OPTI0153HSSMX 00818053025419 OPTI1040CSFMX 00818053025280 OPTI1245CSFMX 00818053025303 OPTI1445CSFMX 00818053025327 OPTI1650CSFMX 00818053025341 OPTI0103CSSMX 00840303701408 OPTI2525CSSMX 00840303701477 OPTI0255CSSMX 00818053025020 OPTI0202CSSMX 00818053024979 OPTI3535CSSMX 00818053025068 OPTI0310CSSMX 00818053025051 OPTI0307CSSMX 00818053025044 OPTI4510CSFMX 00818053025143 OPTI4545CSFMX 00818053025136 OPTI0413CSFMX 00818053025129 OPTI0404CSFMX 00818053025099 OPTI0407CSFMX 00818053025105 OPTI0510CSFMX 00818053025167 OPTI0507CSFMX 00818053025150 OPTI0715CSFMX 00818053025228 OPTI0720CSFMX 00818053025235 OPTI0930CSFMX 00818053025266 The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypotube and distal body coil delivery pusher with a radiopaque distal positioning marker and a proximal fluorosafe marker. The Optima Coil delivery pusher is 185cm in length. It is designed for use with the XCEL Detachment Controller. The XCEL Detachment Controller comes pre-loaded with batteries and is a sterile, handheld, single patient-use device which should not be reused, re-sterilized, opened or tampered with. The Optima Coil achieves detachment by an internal heater element, which is powered by the XCEL Detachment Controller. The Optima Coil System and XCEL Detachment Controller(s) are sold separately.

BALT USA

Class I - Dangerous

Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.

May 8, 2025 Implants & Prosthetics Nationwide View Details →

Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Opti

BALT USA

Class I - Dangerous

Discoloration was identified along the delivery pusher which was attributed to corrosion of the hypotube. The material which caused the corrosion was identified as remnants of solder flux residue remaining on the hypotube component of the delivery pusher. Due to the location of the delivery pusher within the delivery system, it is possible for the discoloration to mechanically break off from the delivery pusher, leaving the potential for the material to flow through the delivery system (i.e. microcatheter), and into the patient vasculature causing foreign emboli.

Jan 3, 2024 Implants & Prosthetics Nationwide View Details →