Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is Recalled by Cordis Corporation Due to Product may not meet the internal manufacturing shaft...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cordis Corporation directly.
Affected Products
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.
Quantity: 162 units total (74 units in USA)
Why Was This Recalled?
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cordis Corporation
Cordis Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report