Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number Lot Number Expiry Date 4400322X 82144115 2020-04-30; 4400602S 82144141 2020-05-31; 4400515X 82144947 2020-06-30; 4400308S 82148810 2020-11-30; and 4400508S 82148811 2020-11-30.
- 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:
- Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for postdilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Product Codes/Lot Numbers:
Catalog Number Lot Number Expiry Date 4400322X 82144115 2020-04-30; 4400602S 82144141 2020-05-31; 4400515X 82144947 2020-06-30; 4400308S 82148810 2020-11-30; and 4400508S 82148811 2020-11-30.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0390-2019
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.