Reported Jun 12, 2013 · Terminated

FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical…

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

FLEXSTENT Femoropopliteal Self-Expanding Stent System
Product UsageThe FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions

Lot codes and dates: 28 Catalog Numbers CAC-50030-V2
CAC-60030-V2
CAC-70030-V2
CAC-80030-V2
CAC-50040-V2
CAC-60040-V2
CAC-70040-V2
CAC-80040-V2
CAC-50060-V2
CAC-60060-V2
CAC-70060-V2
CAC-80060-V2
CAC-50080-V2
CAC-60080-V2
CAC-70080-V2
CAC-80080-V2
CAC-50100-V2
CAC-60100-V2
CAC-70100-V2
CAC-80100-V2
CAC-50120-V2
CAC-60120-V2
CAC-70120-V2
CAC-80120-V2
CAC-50150-V2
CAC-60150-V2
CAC-70150-V2
CAC-80150-V2
Amount recalled: 784 units

The agency filed one notice per product. You are reading one of them; the other 4 are below.

Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.

This product could cause temporary or reversible health problems — stop using it.

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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22 in total.