🔍 RecallPedia

Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

Class I - Dangerous
🏥 Medical Devices Recalled: December 22, 2015 Cook Medical Incorporated Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Prefix ZIVX5. All Lots
  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:
Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

Product Codes/Lot Numbers:

Catalog Prefix ZIVX5. All Lots

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0689-2016

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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.

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