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Cordis Corporation recalls SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant
Recalled November 24, 2021 · FDA recall Z-0219-2022 · Cordis
Hazard
There is a potential for distal tip dislodgement or separation. · FDA Class II
Units
4 units
Sold at
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
Description
There is a potential for distal tip dislodgement or separation.
Product
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Manufacturer(s)
Cordis Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →