BEUDAMED
    FDA Enforcement Class II Terminated

    Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is 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-0067-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0067-2019
    Event ID
    80966
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heartware, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    August 28, 2018
    Classification Date
    October 3, 2018
    Termination Date
    April 5, 2019
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States

    Description

    Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is 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

    Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.

    Code Info

    Serial number range: CON300175 - CON320540

    Distribution

    Worldwide Distribution

    Quantity

    17,275 units