BEUDAMED
    FDA Recall Terminated

    Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303

    Recall: Z-0109-2008 · Initiated September 10, 2007

    Recall

    Recall Number
    Z-0109-2008
    Event Number
    44939
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 10, 2007
    Posted
    October 31, 2007
    Terminated
    December 20, 2007
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Boston Scientific-Renegade Hi-Flo Microcatheter Kit, UPN Material Number: MOO1183030,Catalog Number: 18-303

    Reason

    Incorrect Guidewire: Product may incorrectly contain a 135 cm length Transend-18 guidewire instead of the kit labeled 165 cm length Transend-18 guidewire.

    Action

    Boston Scientific issued a Urgent Medical Device Recall Letter dated September 10, 2007 to Domestic accounts via Federal Express. The notification instructed the account to immediately discontinue the use of the product under this recall, check their inventory, remove any affected product , and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form

    Distribution

    Nationwide

    Quantity

    153