BEUDAMED
    FDA Enforcement Class II Ongoing

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

    Recall: Z-0481-2024 · Reported December 13, 2023

    Enforcement

    Recall Number
    Z-0481-2024
    Event ID
    93405
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heartware, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 13, 2023
    Initiation Date
    October 31, 2023
    Classification Date
    December 1, 2023
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States

    Description

    PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP

    Reason

    Updates to the HVAD system instructions for use (IFU) and patient manual (PM) will be provided. These updates will clarify (1) the conditions under which an HVAD [Controller Fault] alarm may sound and the recommended troubleshooting actions and (2) instructions relating to the useful life of the HVAD system components

    Code Info

    GTIN none, Serial Numbers: HW25172, HW25169FSCA, HW25170FSCA, HW25174FSCA; GTIN 00763000170967, Serial numbers: HW42722, HW42771, HW42285, HW41696, HW41675, HW40953, HW41848, HW41847, HW41316, HW41828, HW41824, HW41803, HW41670, HW41271, HW41701, HW41674, HW41791, HW41792, HW41804, HW41252, HW41256, HW41700, HW41699, HW41783, HW41317, HW41309, HW41673, HW41254, HW40651, HW40665, HW40663, HW41672, HW41308, HW41269, HW41544, HW41270, HW41214, HW41314, HW40417, HW41263, HW41264, HW41265, HW41047, HW41260, HW41266, HW41251, HW41259, HW41258, HW40579, HW41048, HW41262, HW41045, HW40961, HW40958, HW40956, HW41050, HW41255, HW40881, HW40789, HW40957, HW40960, HW40951, HW40659, HW40602, HW40816, HW40954, HW40950, HW40662, HW40664, HW40580, HW40668, HW40613, HW40652, HW40666, HW40667, HW40660, HW40658, HW40612, HW40420, HW40657, HW40607, HW40552, HW40609, HW40599, HW40424, HW40423, HW40426, HW40600, HW40465, HW40553, HW40554, HW40383, HW40603, HW40653, HW40655, HW40656, HW40473, HW40555, HW40472, HW40422, HW40480, HW40564, HW40565, HW40413, HW40479, HW40557, HW40415, HW40476, HW40478, HW40428, HW40429, HW40477, HW40419, HW40421, HW40425, HW40431, HW40471, HW40474, HW40475, HW40412, HW40414, HW40418

    Distribution

    Worldwide

    Quantity

    126 units