BEUDAMED
    FDA Recall Terminated

    Pulsar Max II Multiprogrammable Pacemaker, Model 1280

    Recall: Z-1017-03 · Initiated June 23, 2003

    Recall

    Recall Number
    Z-1017-03
    Event Number
    26561
    Firm
    Guidant Corp-Cpi Division
    FEI Number
    2124215
    Product Code
    DXY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 23, 2003
    Posted
    July 15, 2003
    Terminated
    July 2, 2004
    Address
    4100 N Hamline Ave, St Paul, MN, 55112-5798

    Description

    Pulsar Max II Multiprogrammable Pacemaker, Model 1280

    Reason

    Some of the pacemakers could have failed to pace due to an inadequately soldered electrical connection at an integrated circuit.

    Action

    On June 23, 2003, sales representatives began retrieving any recalled pacemakers, which were not implanted. For implanted pacemakers, an 'Important Patient Management Information' letter, dated June 23, 2003, was sent to physicians recommending that pacemaker-dependent patients, with the potentially affected pacemakers, be scheduled for exams to check for proper pacemaker performance using a programmer.

    Distribution

    Nationwide in the United States and worldwide.

    Quantity

    16 pacemakers