BEUDAMED
    FDA Enforcement Class II Ongoing

    MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

    Recall: Z-1462-2023 · Reported May 3, 2023

    Enforcement

    Recall Number
    Z-1462-2023
    Event ID
    92021
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Datascope Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 3, 2023
    Initiation Date
    April 4, 2023
    Classification Date
    April 26, 2023
    Address
    1300 Macarthur Blvd, N/A, Mahwah, NJ, 07430-2052, United States

    Description

    MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32

    Reason

    The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.

    Code Info

    UDI-DI: 10607567111117; Serial Numbers: CB343612K1 CB351306D2 CB360094J2 CB351302D2 CB343613K1 CB359782J2 CB359780J2 CB320625E0 CH207880C5 CB359783J2 CB328500J0 CB356765G2 CB356763G2 CB314092J9 CB355433F2 CB355432F2 CB351305D2 CB311676I9 CB355435F2 CB319727D0 CB319726D0 CB342653J1 CB307113G9 CB360092J2 CH245699K6 CB307117G9 CB360095J2 CB351303D2 CB320623E0 CB320621E0 CB320620E0 CB311677I9 CB314093J9 CB356761G2 CB351307D2 CB329943K0 CB360093J2 CB307111G9 CB343611K1 CB307114G9 CB320624E0 CB351301D2 CB359781J2 CB351304D2 CB356762G2 CB355434F2 CB322068F0 CB342652J1 CB311675I9 CB320622E0 CB355431F2 CB314094J9 CB307112G9 CB307119G9

    Distribution

    International distribution in the country of Brazil.

    Quantity

    54 units