Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Flexima Duodenal Bend Biliary Stent with Delivery System Recalled by Boston Scientific Corporation Due to The sterile barrier may contain packaging seal defects....
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 Boston Scientific Corporation directly.
Affected Products
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Quantity: 75 units
Why Was This Recalled?
The sterile barrier may contain packaging seal defects.
Where Was This Sold?
This product was distributed to 9 states: AL, CA, IL, MD, PA, TN, TX, UT, WI
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report