FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 27 Catalog Numbers FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1
- 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:
- Cordis Corporation
- Reason for Recall:
- Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Product Codes/Lot Numbers:
27 Catalog Numbers FLX-50030-B1, FLX-60030-B1, FLX-70030-B1, FLX-80030-B1, FLX-50040-B1, FLX-60040-B1, FLX-70040-B1, FLX-80040-B1, FLX-50060-B1, FLX-60060-B1, FLX-70060-B1, FLX-80060-B1, FLX-50080-B1, FLX-60080-B1, FLX-70080-B1, FLX-80080-B1, FLX-50100-B1, FLX-60100-B1, FLX-70100-B1, FLX-80100-B1, FLX-50120-B1, FLX-60120-B1, FLX-70120-B1, FLX-80120-B1, FLX-60150-B1, FLX-70150-B1, FLX-80150-B1
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1507-2013
Related Recalls
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.
There is a potential for distal tip dislodgement or separation.