BEUDAMED
    FDA Enforcement Class I Terminated

    Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E

    Recall: Z-2411-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2411-2020
    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 SPANISH, Product Code IAP-0500E

    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 SPANISH IAP-0500E 150302W 150304W 150402W through 150403W 150408W 150514W 150826W 151014W 151107W 151110W 160425W through 160427W 160508W through 160510W 160518W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH IAP-0500E 160631W 160637W 160642W 160644W 160705W 160919W 170204W through 170206W 170221W 170308W 170328W 170928W 171116W 180333W 180840W 180939W 181054W 181056W through 181060W 190229W 190512W 190514W 190519W 190631W through 190633W

    Distribution

    Worldwide distribution.

    Quantity

    2123 total