🔍 RecallPedia

Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Class I - Dangerous
🏥 Medical Devices Recalled: June 6, 2016 Stryker Neurovascular Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    MODEL Number: M0035421520: Lot Number/Expiration Date: 18571775 31-Aug-18 18826432 31-Jan-19 18820709 31-Jan-19 18810506 31-Jan-19 18771506 31-Dec-18 18742834 31-Dec-18 18641914 31-Oct-18 18660947 31-Oct-18 18432978 30-Jun-18 18825388 31-Jan-19 18810970 31-Jan-19 18820593 31-Jan-19 18758780 31-Dec-18 18789731 31-Jan-19 18742776 31-Dec-18 18721938 30-Nov-18 18676533 30-Nov-18 18633805 31-Oct-18 18641972 31-Oct-18 18825910 31-Jan-19 18826258 31-Jan-19 18701086 30-Nov-18 18742718 31-Dec-18 18676359 30-Nov-18 18700796 30-Nov-18 18666663 31-Oct-18 18625251 31-Oct-18 18642030 31-Oct-18 18598415 30-Sep-18 18534255 31-Aug-18 18821173 28-Feb-19 18810390 31-Jan-19 18789847 31-Jan-19 18789673 31-Jan-19 18758370 31-Dec-18 18728186 30-Nov-18 18700680 30-Nov-18 18625135 30-Sep-18 18576927 30-Sep-18 18534545 31-Aug-18 18487470 31-Jul-18 18460621 30-Jun-18 18826084 31-Jan-19 18825736 31-Jan-19 18825562 31-Jan-19 18810738 31-Jan-19 18820941 31-Jan-19 18820825 31-Jan-19 18778633 31-Dec-18 18742950 31-Dec-18 18714130 30-Nov-18 18666489 31-Oct-18 18625193 30-Sep-18 18629461 31-Oct-18 18590180 30-Sep-18 18562973 31-Aug-18 18534023 31-Aug-18 18563089 31-Aug-18 18406635 31-May-18 18642088 31-Oct-18 18810622 31-Jan-19 18778428 31-Dec-18 18789963 31-Jan-19 18771622 31-Dec-18 18722727 30-Nov-18 18701028 30-Nov-18 18648913 31-Oct-18 18666547 31-Oct-18 18590354 30-Sep-18 18563263 31-Aug-18 18821057 31-Jan-19 18771042 31-Dec-18 18742660 31-Dec-18 18700970 30-Nov-18 18660831 31-Oct-18 18563321 31-Aug-18 18582739 30-Sep-18 18559308 31-Aug-18 18482415 30-Jun-18 18439457 30-Jun-18 18789905 31-Jan-19 18810854 31-Jan-19 18820477 31-Jan-19 18789789 31-Jan-19 18758575 31-Dec-18 18742892 30-Nov-18 18700912 30-Nov-18 18700622 30-Nov-18 18660889 31-Oct-18 18642146 31-Oct-18 18641856 31-Oct-18 18563147 31-Aug-18 18439343 30-Jun-18 18397945 31-May-18 19055171 31-May-19 19028965 30-Apr-19 19028733 30-Apr-19 18991622 30-Apr-19 19070054 31-May-19 19069822 31-May-19 19014397 30-Apr-19 18948006 31-Mar-19 18977668 30-Apr-19 18934071 31-Mar-19 18933781 31-Mar-19 18896026 28-Feb-19 18870593 28-Feb-19 18870941 28-Feb-19 18848567 31-Jan-19 19055055 31-May-19 18979060 30-Apr-19 18871174 28-Feb-19 18882282 28-Feb-19 18934013 31-Mar-19 18933955 31-Mar-19 18870712 28-Feb-19 18870833 28-Feb-19 18848451 28-Feb-19 18991796 30-Apr-19 19075803 31-May-19 18947658 31-Mar-19 18933897 31-Mar-19 18914143 31-Mar-19 18913354 28-Feb-19 18870480 28-Feb-19 18881934 28-Feb-19 18848277 31-Jan-19 19055519 31-May-19 19055403 31-May-19 19054939 31-May-19 19070518 31-May-19 19014455 30-Apr-19 18947136 31-Mar-19 18934129 31-Mar-19 18882166 28-Feb-19 19029197 30-Apr-19 19029661 30-Apr-19 19043814 31-May-19 19043547 31-May-19 19070750 31-May-19 19070286 31-May-19 19014165 30-Apr-19 19014513 30-Apr-19 19014223 30-Apr-19 18963440 31-Mar-19 18977900 30-Apr-19 18954755 31-Mar-19 18933839 31-Mar-19 18895736 28-Feb-19 18848509 31-Jan-19 18914406 31-Mar-19 18871055 28-Feb-19 19043725 31-May-19 19014281 30-Apr-19 19014339 30-Apr-19 18964832 31-Mar-19 18978364 30-Apr-19 18913880 31-Mar-19 18882398 28-Feb-19 18882050 28-Feb-19 18882514 28-Feb-19 18848335 31-Jan-19 19055635 31-May-19 19001678 30-Apr-19 18963904 31-Mar-19 18978596 30-Apr-19 18978132 30-Apr-19 18955661 31-Mar-19 18947832 31-Mar-19 18947310 31-Mar-19 18895156 28-Feb-19 18895446 28-Feb-19 18896316 28-Feb-19 19055287 31-May-19 19029429 30-Apr-19 18991100 30-Apr-19 19043636 31-May-19 19001620 30-Apr-19 18964368 31-Mar-19 18978828 30-Apr-19 18913617 31-Mar-19 18948180 31-Mar-19 18947484 31-Mar-19 18881818 28-Feb-19 18871292 28-Feb-19 18848393 28-Feb-19.
  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:
Stryker Neurovascular
Reason for Recall:
Stryker Neurovascular has become aware that some units of Target Nano product do not have the intended stretch resistance. The sutures inside the coil that provide stretch resistance may have been damaged during manufacturing which can lead to an increased occurrence of coil stretching.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M0035421520 Neurology: Target Detachable Coils are intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.

Product Codes/Lot Numbers:

MODEL Number: M0035421520: Lot Number/Expiration Date: 18571775 31-Aug-18 18826432 31-Jan-19 18820709 31-Jan-19 18810506 31-Jan-19 18771506 31-Dec-18 18742834 31-Dec-18 18641914 31-Oct-18 18660947 31-Oct-18 18432978 30-Jun-18 18825388 31-Jan-19 18810970 31-Jan-19 18820593 31-Jan-19 18758780 31-Dec-18 18789731 31-Jan-19 18742776 31-Dec-18 18721938 30-Nov-18 18676533 30-Nov-18 18633805 31-Oct-18 18641972 31-Oct-18 18825910 31-Jan-19 18826258 31-Jan-19 18701086 30-Nov-18 18742718 31-Dec-18 18676359 30-Nov-18 18700796 30-Nov-18 18666663 31-Oct-18 18625251 31-Oct-18 18642030 31-Oct-18 18598415 30-Sep-18 18534255 31-Aug-18 18821173 28-Feb-19 18810390 31-Jan-19 18789847 31-Jan-19 18789673 31-Jan-19 18758370 31-Dec-18 18728186 30-Nov-18 18700680 30-Nov-18 18625135 30-Sep-18 18576927 30-Sep-18 18534545 31-Aug-18 18487470 31-Jul-18 18460621 30-Jun-18 18826084 31-Jan-19 18825736 31-Jan-19 18825562 31-Jan-19 18810738 31-Jan-19 18820941 31-Jan-19 18820825 31-Jan-19 18778633 31-Dec-18 18742950 31-Dec-18 18714130 30-Nov-18 18666489 31-Oct-18 18625193 30-Sep-18 18629461 31-Oct-18 18590180 30-Sep-18 18562973 31-Aug-18 18534023 31-Aug-18 18563089 31-Aug-18 18406635 31-May-18 18642088 31-Oct-18 18810622 31-Jan-19 18778428 31-Dec-18 18789963 31-Jan-19 18771622 31-Dec-18 18722727 30-Nov-18 18701028 30-Nov-18 18648913 31-Oct-18 18666547 31-Oct-18 18590354 30-Sep-18 18563263 31-Aug-18 18821057 31-Jan-19 18771042 31-Dec-18 18742660 31-Dec-18 18700970 30-Nov-18 18660831 31-Oct-18 18563321 31-Aug-18 18582739 30-Sep-18 18559308 31-Aug-18 18482415 30-Jun-18 18439457 30-Jun-18 18789905 31-Jan-19 18810854 31-Jan-19 18820477 31-Jan-19 18789789 31-Jan-19 18758575 31-Dec-18 18742892 30-Nov-18 18700912 30-Nov-18 18700622 30-Nov-18 18660889 31-Oct-18 18642146 31-Oct-18 18641856 31-Oct-18 18563147 31-Aug-18 18439343 30-Jun-18 18397945 31-May-18 19055171 31-May-19 19028965 30-Apr-19 19028733 30-Apr-19 18991622 30-Apr-19 19070054 31-May-19 19069822 31-May-19 19014397 30-Apr-19 18948006 31-Mar-19 18977668 30-Apr-19 18934071 31-Mar-19 18933781 31-Mar-19 18896026 28-Feb-19 18870593 28-Feb-19 18870941 28-Feb-19 18848567 31-Jan-19 19055055 31-May-19 18979060 30-Apr-19 18871174 28-Feb-19 18882282 28-Feb-19 18934013 31-Mar-19 18933955 31-Mar-19 18870712 28-Feb-19 18870833 28-Feb-19 18848451 28-Feb-19 18991796 30-Apr-19 19075803 31-May-19 18947658 31-Mar-19 18933897 31-Mar-19 18914143 31-Mar-19 18913354 28-Feb-19 18870480 28-Feb-19 18881934 28-Feb-19 18848277 31-Jan-19 19055519 31-May-19 19055403 31-May-19 19054939 31-May-19 19070518 31-May-19 19014455 30-Apr-19 18947136 31-Mar-19 18934129 31-Mar-19 18882166 28-Feb-19 19029197 30-Apr-19 19029661 30-Apr-19 19043814 31-May-19 19043547 31-May-19 19070750 31-May-19 19070286 31-May-19 19014165 30-Apr-19 19014513 30-Apr-19 19014223 30-Apr-19 18963440 31-Mar-19 18977900 30-Apr-19 18954755 31-Mar-19 18933839 31-Mar-19 18895736 28-Feb-19 18848509 31-Jan-19 18914406 31-Mar-19 18871055 28-Feb-19 19043725 31-May-19 19014281 30-Apr-19 19014339 30-Apr-19 18964832 31-Mar-19 18978364 30-Apr-19 18913880 31-Mar-19 18882398 28-Feb-19 18882050 28-Feb-19 18882514 28-Feb-19 18848335 31-Jan-19 19055635 31-May-19 19001678 30-Apr-19 18963904 31-Mar-19 18978596 30-Apr-19 18978132 30-Apr-19 18955661 31-Mar-19 18947832 31-Mar-19 18947310 31-Mar-19 18895156 28-Feb-19 18895446 28-Feb-19 18896316 28-Feb-19 19055287 31-May-19 19029429 30-Apr-19 18991100 30-Apr-19 19043636 31-May-19 19001620 30-Apr-19 18964368 31-Mar-19 18978828 30-Apr-19 18913617 31-Mar-19 18948180 31-Mar-19 18947484 31-Mar-19 18881818 28-Feb-19 18871292 28-Feb-19 18848393 28-Feb-19.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2162-2016

Related Recalls

The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiopaque shaft and distal marker(s) facilitate fluoroscopic visualization. A rotating hemostatic valve with side-arm adapter is provided with each microcatheter.

Stryker Neurovascular

Class I - Dangerous

Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed to customers in the US.

Aug 30, 2024 Surgical Instruments Nationwide View Details →

The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque.

Stryker Neurovascular

Class I - Dangerous

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

Apr 18, 2024 Diagnostic Equipment Nationwide View Details →

The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.

Stryker Neurovascular

Class I - Dangerous

Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

Apr 18, 2024 Diagnostic Equipment Nationwide View Details →