Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Recalled by Boston Scientific Corporation Due to Complaints of device fragmentation after the catheter was...
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
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Quantity: 289
Why Was This Recalled?
Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods and, in some of the reported cases, this was performed to retrieve the device fragments.
Where Was This Sold?
This product was distributed to 4 states: CA, FL, OH, 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