BEUDAMED
    FDA Recall Terminated

    CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175; CONTACT RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.

    Recall: Z-0956-05 · Initiated June 17, 2005

    Recall

    Recall Number
    Z-0956-05
    Event Number
    32391
    Firm
    Boston Scientific CRM Corp
    FEI Number
    2124215
    Product Code
    LWP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 17, 2005
    Posted
    June 30, 2005
    Terminated
    March 2, 2008
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    CONTACT RENEWAL 3 AVT model numbers M150 and M155; CONTACT RENEWAL 3 AVT HE model numbers M157 and M159; CONTACT RENEWAL 4 AVT model numbers M170 and M175; CONTACT RENEWAL 4 AVT HE model numbers M177 and M179. Cardiac Resynchronization Therapy Defibrillator. Sterilized using gaseous ethylene oxide. Guidant Corporation Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798, USA. CONTAK RENEWAK AVT models provide both atrial and ventricular tachyarrhythmia and cardiac resynchronization therapies.

    Reason

    The atrial therapy (AVT) subgroups of certain Guidant ICD and CRT-D product families are subject to a condition in which a random memory error causes functional 'latching' that limits available therapy.

    Action

    Firm issued a Dr. Doctor letter dated 06/17/05. Letter informs physicians of the issue, clinical implications, recommendations and action taken by the firm.

    Distribution

    worldwide. To the US and OUS countries to include: Argentina, Australia, Austria, Belgium, Canada, Chile, Cyprus, Denmark, France, Germany, Guadeloupe, Hong Kong, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Syrian Arab Republic, Turkey, US - Virgin Islands and United Kingdom.

    Quantity

    2,204 devices (786 remain implanted worldwide)