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Terminated

Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter.

FDA Recall Z-1336-2015 · Posted 2015-03-27

Recall StatusTerminated
Product CodeFGE
Date Initiated2015-02-25
Date Terminated2016-08-12
Product Quantity918

Reason for Recall

Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for device fragmentation after an Expel" APD catheter was implanted in the biliary system. The most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive meth

Firm Action

Boston Scientific sent an "Urgent Medical Device Correction" letter dated February 25, 2015, to all affected customers. The letter described the problem and the product involved in the recall. The letter informed customers not to use the Expel APD and APDL Drainage catheters for bile drainage and to complete and return the Customer Acknowledgement Form. The letter also noted that the devices are not being retrieved and they are not required to return them to Boston Scientific. For further questions please call (763) 494-7971.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Distribution to the states of : CA, LA, FL, WI, NY, IL, MD 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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