BEUDAMED
    FDA Enforcement Class I Terminated

    Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

    Recall: Z-2417-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2417-2020
    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 AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701

    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: AC3 Optimus IABP NA/AJLA IAP-0701 170831F through 170840F 171011F through 171020F 171121F through 171125F 180106F through 180110F 180126F through 180130F 180426F through 180430F 180606F through 180610F 180731F through 180740F 180826F through 180830F 180901F through 180910F 180912F through 180921F 181001F through 181010F 190136F through 190140F 190336F through 190340F 190646F through 190650F 190731F through 190736F 190931F through 190936F 191019F through 191024F 191055F through 191060F 200107F through 200112F 200308F through 200311F

    Distribution

    Worldwide distribution.

    Quantity

    2123 total