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Recall Observatory FDA recall evidence

Device product

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

Z-1509-2013

April 23, 2013

Class II

Product summary

Firm
Cordis Corporation
Event
Event 65182
Status
Terminated
Classification
Class II
Quantity
1357 units
Official record key
device-enforcement:Z-1509-2013

Official wording

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

Code information: 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

Distribution pattern: Worldwide Distribution - USA (nationwide) and the states of: AZ, CA, CT, FL, GA, IA, IL, LA, MD, MI, MS, NC, NJ, NY, OH, PA, RI, SC, TX, WA, WI, WV, and the countries of: Czech Republic, Italy, Netherlands, and New Zealand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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