BEUDAMED
    FDA Recall 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 · Initiated December 18, 2013

    Recall

    Recall Number
    Z-0710-2014
    Event Number
    67139
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FGE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 18, 2013
    Posted
    January 10, 2014
    Terminated
    August 19, 2014
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    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

    Action

    Boston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. For questions regarding this recall call 508-382-9555.

    Distribution

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

    Quantity

    39 units