medical Class II Updated 2018-11-14

Cordis Corporation recalls Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage

Recalled 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.


Hazard / Issue

Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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.
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