Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M005471...
FDA Recall #Z-0710-2014 — Class II — December 18, 2013
Product Description
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.
Reason for Recall
Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Recalling Firm
Boston Scientific Corporation — Marlborough, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
39 units
Distribution
Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
Code Information
Lot Number:16231178
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated