BEUDAMED
    FDA Recall Terminated

    Medtronic CapSureFix Novus Lead Model 5076.

    Recall: Z-0207-05 · Initiated October 20, 2004

    Recall

    Recall Number
    Z-0207-05
    Event Number
    30369
    Firm
    Medtronic Inc. Cardiac Rhythm Managment
    FEI Number
    2182208
    Product Code
    DTA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 20, 2004
    Posted
    November 17, 2004
    Terminated
    January 24, 2005
    Address
    7000 Central Ave Ne, Fridley, MN, 55432

    Description

    Medtronic CapSureFix Novus Lead Model 5076.

    Reason

    A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.

    Action

    Letter of October 20, 2004, to direct customers, advised them to work with their respective Medtronic representatives to locate all leads and return them to Medtronic.

    Distribution

    Leads were distributed to 21 consignees (hospitals/clinics) throughout the US.

    Quantity

    35 incorrectly labeled leads were distributed to customers.