BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0710-2014 · Reported January 22, 2014

    Enforcement

    Recall Number
    Z-0710-2014
    Event ID
    67139
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 22, 2014
    Initiation Date
    December 18, 2013
    Classification Date
    January 10, 2014
    Termination Date
    August 19, 2014
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234, United States

    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

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

    Code Info

    Lot Number:16231178

    Distribution

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

    Quantity

    39 units