BEUDAMED
    FDA Recall Terminated

    Alto implantable cardioverter defibrillator

    Recall: Z-0176-05 · Initiated October 21, 2004

    Recall

    Recall Number
    Z-0176-05
    Event Number
    30273
    Firm
    ela Medical Llc
    FEI Number
    2182863
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 21, 2004
    Posted
    November 4, 2004
    Terminated
    November 14, 2005
    Address
    2950 Xenium Ln N, Ste 120, Plymouth, MN, 55441-2623

    Description

    Alto implantable cardioverter defibrillator

    Reason

    Alto Implantable Defibrillators Models 614 and 615. These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.

    Action

    The company observed occurrences of premature battery depletion and/or prolonged charge time for some Alto 614 and Alto 615 devices. The firm is requesting physician's assistance to monitor the performance of a limited number of implanted Alto 614 and 615 devices.

    Distribution

    Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product. ELA Medical has contacted physicians who follow patients implanted with the devices that are the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.

    Quantity

    434 users recived the product