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Recall Observatory FDA recall evidence

Device product

SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Z-0221-2022

October 01, 2021

Class II

Product summary

Firm
Cordis Corporation
Event
Event 88821
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-0221-2022

Official wording

Reason: There is a potential for distal tip dislodgement or separation.

Code information: Product Code: SF10100MB; Lot No. 271626

Distribution pattern: US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for distal tip dislodgement or separation.