BEUDAMED
    FDA Recall Terminated

    CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.

    Recall: Z-0907-05 · Initiated June 17, 2005

    Recall

    Recall Number
    Z-0907-05
    Event Number
    32380
    Firm
    Guidant Corporation
    FEI Number
    2124215
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 17, 2005
    Posted
    June 30, 2005
    Terminated
    January 10, 2007
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    CONTAK RENEWAL (model H135) Heart Failure Device Cardiac Resynchronization Therapy Defibrillators (CRT-Ds). Sterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798. USA. Renewal provides ventricular tachyarrhythmia and cardiac resynchronization therapies.

    Reason

    Laboratory analysis revealed that a deterioration in a wire insulator within the lead connector block, in conjunction with other factors, could cause a short circuit and loss of device function due to diversion of therapy energy away from the heart and into device circuitry.

    Action

    Dear Doctor letter was dated and issued 06/17/05 informing Doctors of an shorting issue of the Renewal 1 & 2 CRT-D devices. The letter gave indications of device failure and recommendations for patient visits. A press release was also issued on 06/17/05.

    Distribution

    worldwide. Including the United States and countries such as: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czech Republic, Czechoslovakia, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Turkey, United Kingdom and Venezuela.

    Quantity

    16,000 (Approximately 11,900 remain implanted worldwide)