Boston Scientific Corporation recalls Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro X

Recalled January 22, 2014 · FDA recall Z-0710-2014 · Boston Scientific

Hazard

Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size · FDA Class II

Units

39 units

Sold at

Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.

Description

Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

Product

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.

Manufacturer(s)

Boston Scientific Corporation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →