Reported Nov 14, 2018 · Terminated
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral,…
Cordis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cordis Corporation · 14201 NW 60th Ave · Miami Lakes, FL · 33014-2802
Is this the product you have?
- Cordis POWERFLEX PRO
- PTA Dilatation Catheter - Product UsageIs 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
- Lot codes and dates
- 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.
- Amount recalled
- 162 units total (74 units in USA)
Where it was sold
Why it was recalled
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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