BEUDAMED
    FDA Enforcement Class I Terminated

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

    Recall: Z-2415-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2415-2020
    Event ID
    85684
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2020
    Initiation Date
    May 20, 2020
    Classification Date
    June 26, 2020
    Termination Date
    January 7, 2023
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

    Reason

    A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.

    Code Info

    Serial Number Range: AEROAUTOCAT 2 WAVE IAP-0535 150907W 151030W 151101W 151104W 151106W 160305W through 160306W 160743W 160824W 190119W through 190120W 190221W 190223W through 190226W 191047W

    Distribution

    Worldwide distribution.

    Quantity

    2123 total