BEUDAMED
    FDA Recall Open, Classified

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

    Recall: Z-0475-2024 · Initiated October 31, 2023

    Recall

    Recall Number
    Z-0475-2024
    Event Number
    93405
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Labeling design
    Initiated
    October 31, 2023
    Posted
    December 2, 2023
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    Description

    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100

    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

    Action

    Heartware issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 10/31/2023 via letter (UPS). The notice explained the issue and informed them of the updates to the HVAD IFU and PM (patient manual).

    Distribution

    Worldwide

    Quantity

    45 units