Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product # Lot # DL900J GFZJ0450 DL900J GFZJ0452 DL900J GFZJ0455 DL900J GFZK0303 DL900J GFZJ0454 DL900J GFZK0304 DL900J GFZK0306 DL950J GFZJ1176 DL950J GFZJ1177 DL900J GFZK0309 DL900J GFZK0305 DL900J GFZK0308 DL900J GFZJ0456 DL900J GFZK0307 DL900J GFZJ0460 DL900J GFZJ0459 DL900J GFZK0310 DL900J GFZK0311 DL900J GFZK0314 DL900J GFZK0313 DL900J GFZK0312 DL900J GFZK0315 DL900J GFZK0316 DL900J GFZK0317 DL900J GFZK0358 DL900J GFZK0318 DL900J GFZK0319 DL900J GFZK0360 DL900J GFZK0361 DL950J GFZK0350 DL900J GFZK0359 DL900J GFZK0362 DL900J GFZK0363 DL900J GFZK0365 DL900J GFZK0344 DL900J GFZK0345 DL900J GFZK0346 DL950J GFZK2376 DL900J GFZK3551 DL900J GFZK3553 DL900J GFZK3555 DL900J GFZK3552 DL900J GFZK3554 DL900J GFZK3557 DL900J GFZK0340 DL900J GFZK0341 DL900J GFZK0342 DL900J GFZK0343 DL900J GFZK0348 DL900J GFZK0349 DL900J GFZK3556 DL900J GFZK0347 DL900J GFZK3558 DL900J GFZK3559 DL900J GFZK3560 DL900J GFZK3561
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Bard Peripheral Vascular Inc
- Reason for Recall:
- Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
Product Codes/Lot Numbers:
Product # Lot # DL900J GFZJ0450 DL900J GFZJ0452 DL900J GFZJ0455 DL900J GFZK0303 DL900J GFZJ0454 DL900J GFZK0304 DL900J GFZK0306 DL950J GFZJ1176 DL950J GFZJ1177 DL900J GFZK0309 DL900J GFZK0305 DL900J GFZK0308 DL900J GFZJ0456 DL900J GFZK0307 DL900J GFZJ0460 DL900J GFZJ0459 DL900J GFZK0310 DL900J GFZK0311 DL900J GFZK0314 DL900J GFZK0313 DL900J GFZK0312 DL900J GFZK0315 DL900J GFZK0316 DL900J GFZK0317 DL900J GFZK0358 DL900J GFZK0318 DL900J GFZK0319 DL900J GFZK0360 DL900J GFZK0361 DL950J GFZK0350 DL900J GFZK0359 DL900J GFZK0362 DL900J GFZK0363 DL900J GFZK0365 DL900J GFZK0344 DL900J GFZK0345 DL900J GFZK0346 DL950J GFZK2376 DL900J GFZK3551 DL900J GFZK3553 DL900J GFZK3555 DL900J GFZK3552 DL900J GFZK3554 DL900J GFZK3557 DL900J GFZK0340 DL900J GFZK0341 DL900J GFZK0342 DL900J GFZK0343 DL900J GFZK0348 DL900J GFZK0349 DL900J GFZK3556 DL900J GFZK0347 DL900J GFZK3558 DL900J GFZK3559 DL900J GFZK3560 DL900J GFZK3561
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1068-2016
Related Recalls
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Bard Peripheral Vascular
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.
Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
Bard Peripheral Vascular
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.