BEUDAMED
    FDA Recall Terminated

    Tachos DR - Implantable Cardioverter Defibrillator.

    Recall: Z-0700-03 · Initiated February 21, 2003

    Recall

    Recall Number
    Z-0700-03
    Event Number
    25629
    Firm
    Biotronik Inc
    FEI Number
    1028232
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 21, 2003
    Posted
    April 1, 2003
    Terminated
    September 8, 2003
    Address
    6024 Jean Road, Lake Oswego, OR, 97035-5369

    Description

    Tachos DR - Implantable Cardioverter Defibrillator.

    Reason

    Potential for battery to delivery less than full amount of energy.

    Action

    The firm issued an 'URGENT - VOLUNTARY MEDICAL DEVICE' recall letter dated 2/21/03 to the physicians. This letter explains the issue and recommends scheduling an immediate follow-up with the patients. The letter describes conditions under which the patient should be monitored on a weekly basis (versus every 3 months), and under which conditions the device should be explanted.

    Distribution

    The firm distributed devices to doctors located throughout the U.S. There is no international distribution from this firm.

    Quantity

    240 (225 still implanted)