Cordis Corporation recalls SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malign…

Recall date

October 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0221-2022

FDA classification

Class II

Brand / firm

Cordis Corporation

Sold / distributed

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

Why it was recalled

There is a potential for distal tip dislodgement or separation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.