BEUDAMED
    FDA Recall Terminated

    Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200

    Recall: Z-0625-03 · Initiated January 31, 2003

    Recall

    Recall Number
    Z-0625-03
    Event Number
    25514
    Firm
    Medtronic, Inc.
    FEI Number
    1220452
    Product Code
    LOX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 31, 2003
    Posted
    March 6, 2003
    Terminated
    May 1, 2003
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923

    Description

    Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200

    Reason

    PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon

    Action

    Medtronic AVE notified the two distributors in Japan on 1/31/2003 who will notify the sales representative to retrieve product from the hospital accounts.Product will be returned to Danvers, accounted and scrapped.

    Distribution

    Japan

    Quantity

    602 units