BEUDAMED
    FDA Enforcement Class II Ongoing

    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    Recall: Z-2072-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2072-2021
    Event ID
    88135
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heartware, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 21, 2021
    Initiation Date
    May 28, 2021
    Classification Date
    July 13, 2021
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    Reason

    The pump has an impeller with a shroud height that did not meet the lower control limit.

    Code Info

    UDI: 00888707007139. Serial Number HW42843

    Distribution

    International distribution to the country of Germany.

    Quantity

    1 unit