BEUDAMED
    FDA Recall Terminated

    PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

    Recall: Z-1064-05 · Initiated June 16, 2005

    Recall

    Recall Number
    Z-1064-05
    Event Number
    32495
    Firm
    Guidant Corporation
    FEI Number
    2124215
    Product Code
    KRG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 16, 2005
    Posted
    August 3, 2005
    Terminated
    November 17, 2005
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    PRIZM 2 DR, model 1861 Automatic Implantable Cardioverter Defibrillator. Contents have been Sterilized with gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA.

    Reason

    Devices were manufactured with PEEK insulation material on the feedthrough wires and distributed prior to PMAS approval.

    Action

    Sales Representatives notified 06/16/05 to return devices in their area.

    Distribution

    CA, IL, MI, MO, OR and PA

    Quantity

    13