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Cordis Corporation recalls Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-fem
Recalled November 14, 2018 · FDA recall Z-0390-2019 · Cordis
Hazard
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test). · FDA Class II
Units
162 units total (74 units in USA)
Sold at
Worldwide distribution - US Nationwide in the states of AL, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MO, MS, NC, ND, NJ, OH, PA, SC, TN, TX, and WI. Countries of Japan and Netherlands.
Description
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
Product
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.
Manufacturer(s)
Cordis Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →