Cordis POWERFLEX PRO PTA Dilatation Catheter 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 post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Class I - Dangerous

🏥 Medical Devices Recalled: December 22, 2014 Cordis Implants & Prosthetics Nationwide

What Should You Do?

Check if you have this product:
Catalog 4400615X, demo lot 15617883
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:: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
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 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 post- dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.