Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SMART FLEX 10x100 BIL Recalled by Cordis Corporation Due to There is a potential for distal tip dislodgement...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cordis Corporation directly.
Affected Products
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.
Quantity: 4 units
Why Was This Recalled?
There is a potential for distal tip dislodgement or separation.
Where Was This Sold?
This product was distributed to 7 states: CA, FL, IN, LA, OH, OK, TX
About Cordis Corporation
Cordis Corporation has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report