🔍 RecallPedia

Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

Class I - Dangerous
🏥 Medical Devices Recalled: September 25, 2018 Cook Medical Incorporated Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    GPN: G36022
  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:
Cook Medical Incorporated
Reason for Recall:
The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.

Product Codes/Lot Numbers:

GPN: G36022

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0336-2019

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Cook Medical Incorporated

Class I - Dangerous

Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

Sep 18, 2025 Other Medical Devices Nationwide View Details →