BEUDAMED
    FDA Recall Terminated

    Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.

    Recall: Z-1582-2009 · Initiated April 9, 2009

    Recall

    Recall Number
    Z-1582-2009
    Event Number
    52223
    FEI Number
    2025845
    Product Code
    DRN
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 9, 2009
    Posted
    July 7, 2009
    Terminated
    August 27, 2012
    Address
    Cardiomedics Incorporated 7 Whatney Suite B, Irvine, CA, 92618-2839

    Description

    Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.

    Reason

    Cuff may underinflate, or device may stop working during use. Cardioassist software version 4.3.1 utilized a signal from the plethysmograph that was found not to be sensitive enough due to the shape of the waveform in certain circumstances where there was excessive motion artifact.

    Action

    Service visit to customer in May 2009 to upgrade and validate CardioAssist 4000 software to version 4.3.5.

    Distribution

    Florida

    Quantity

    1