Reported Jun 12, 2013 · Terminated

FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for…

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 Biliary Self-Expanding Stent System
Product UsageThe FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree

Lot codes and dates: 27 Catalog Numbers FLX-50030-B2
FLX-60030-B2
FLX-70030-B2
FLX-80030-B2
FLX-50040-B2
FLX-60040-B2
FLX-70040-B2
FLX-80040-B2
FLX-50060-B2
FLX-60060-B2
FLX-70060-B2
FLX-80060-B2
FLX-50080-B2
FLX-60080-B2
FLX-70080-B2
FLX-80080-B2
FLX-50100-B2
FLX-60100-B2
FLX-70100-B2
FLX-80100-B2
FLX-50120-B2
FLX-60120-B2
FLX-70120-B2
FLX-80120-B2
FLX-60150-B2
FLX-70150-B2
FLX-80150-B2
Amount recalled: 1357 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.