Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M0054...
FDA Recall #Z-0712-2014 — Class II — December 18, 2013
Product Description
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Below UPN :M00547140
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
34 units
Distribution
Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
Code Information
Lot Number: 16230354
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated