BEUDAMED
    FDA Recall Terminated

    Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256

    Recall: Z-0341-03 · Initiated November 4, 2002

    Recall

    Recall Number
    Z-0341-03
    Event Number
    25102
    FEI Number
    2017865
    Product Code
    DXY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 4, 2002
    Posted
    December 18, 2002
    Terminated
    December 14, 2004
    Address
    St Jude Medical 15900 Valley View Court, Sylmar, CA, 91342

    Description

    Pulse Generators (aka pacemakers) Models include: Z-031-1 Meta DDR, Model 1256D Z-032-1 Tempo VR, Model 1102 Z-033-1 Tempo V, Model 1902 Z-034-1 Tempo DR, Model 2101 Z-035-1 Tempo D, Model 2902 Z-036-1 Meta, Model 1256

    Reason

    Potential loss of pacing function. Expansion of recalls Z-031-1 thru Z-036-1

    Action

    Firm issued 'Dear Doctor' letters to following physicians which listed patient''s that the Doctor was responsible for. The letter informs of the situation regarding the potential loss of pacing function and recommends that the professional healthcare provider review and evaluate patients with the affected devices as soon as possible. Additional conditions to consider are specified for pacemaker dependent versus nondependent patients.

    Distribution

    Nationwide and Australia, Austria, Belgium, Brazil, Canada, Cyprus, Czech Rep., France, Germany, Italy, Netherlands, Spain, Turkey, Venezuela.

    Quantity

    1146