BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated May 28, 2021

    Recall

    Recall Number
    Z-2072-2021
    Event Number
    88135
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 28, 2021
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    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.

    Action

    The firm initiated the recall to the sole consignee on 05/28/2021 by telephone. The consignee was asked to quarantine and return the affected device.

    Distribution

    International distribution to the country of Germany.

    Quantity

    1 unit