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Terminated

Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits

FDA Recall Z-1355-2015 · Posted 2015-03-31

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2015-02-25
Date Terminated2017-06-30
Product Quantity289

Reason for Recall

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.

Firm Action

Boston Scientific sent an Urgent Medical Device Correction - Immediate Action Required letter dated February 5, 2015. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the problem and the product involved in the recall. Advised consignees to complete and return the "Recall Removal Reply Verification Tracking Form". Your local Sales Representative can answer any questions you may have regarding this Field Correction notice. For further questions please call (763) 494- 7971.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : CA, WI, FL and OH., and to the countries of: Belgium, Czech Republic, Finland, France, Germany, Great Britain, Italy, Spain, Switzerland, Austria, Hungary, Netherlands and Portugal.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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