BEUDAMED
    FDA Recall Terminated

    Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

    Recall: Z-2754-2011 · Initiated June 8, 2011

    Recall

    Recall Number
    Z-2754-2011
    Event Number
    59111
    Firm
    Medtronic Vascular
    FEI Number
    1220452
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    June 8, 2011
    Terminated
    April 17, 2012
    Address
    35-37A Cherry Hill Drive, Danvers, MA, 01923-2565

    Description

    Medtronic 6F Zuma Guide Catheter with AL 1.5 Curve with side holes Catalog Number: Z26AL15SH The Medtronic Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The guiding catheter is intended to be used in the coronary or peripheral vascular system.

    Reason

    Mislabeled; Product labeled as 6F Zuma Guide with AL 1.5 curve with side holes may contain a 5F Zuma Catheter with SAL 1.0 curve

    Action

    The firm, Medtronic, sent an "Urgent Medical Device Recall Notice(for US)" letter dated June 7, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to segregate the product so that it will not be used. A Medtronic Sales Representative will visit the customers to account for all units they received and initiate a credit as appropriate. If you have any questions, please call (978) 739-0371 or (978) 739-3259.

    Distribution

    Nationwide distribution: USA including states of: CA, FL, and MA.

    Quantity

    5 units