BEUDAMED
    FDA Enforcement Class I Terminated

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

    Recall: Z-2413-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2413-2020
    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 AUTOCAT2 WAVE JAPANESE, Product Code IAP-0500J

    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 Ranges: AUTOCAT2 WAVE JAPANESE IAP-0500J 140866W through 140867W 150117W through 150118W 150120W 150201W 150305W 150307W through 150309W 150623W through 150624W 150713W through 150716W 151114W 151209W 151213W 151219W 160503W 160511W through 160515W 160517W 160635W through 160636W 160640W through 160641W 160731W through 160733W 171105W 171117W 171119W through 171120W 171201W 180120W 180301W

    Distribution

    Worldwide distribution.

    Quantity

    2123 total