Boston Scientific Corporation recalls Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit,…

Recall date

February 25, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1336-2015

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.