BEUDAMED
    FDA Enforcement Class I Ongoing

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

    Recall: Z-0426-2023 · Reported December 21, 2022

    Enforcement

    Recall Number
    Z-0426-2023
    Event ID
    91021
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ARROW INTERNATIONAL Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2022
    Initiation Date
    October 17, 2022
    Classification Date
    December 15, 2022
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump

    Reason

    There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.

    Code Info

    UDI/DI (01) 0 0801902 05172 1, (01) 0 0801902 05172 2, All Lot/Serial Numbers

    Distribution

    Worldwide

    Quantity

    1394 units