Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Recalled by Cordis Corporation Due to Holes and/or tears can be introduced in the...
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
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.
Quantity: 23 units
Why Was This Recalled?
Holes and/or tears can be introduced in the FLEXSTENT¿ inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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