BEUDAMED
    FDA Recall 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 · Initiated August 28, 2018

    Recall

    Recall Number
    Z-0067-2019
    Event Number
    80966
    Firm
    Heartware, Inc.
    FEI Number
    3007042319
    Product Code
    DSQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 28, 2018
    Terminated
    April 5, 2019
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807

    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.

    Action

    Medtronic began notifying Clinicians in the US on 28-Aug-2018 mainly via 2-day courier, of the identified issues and provided patient management recommendations. Outside the US, Medtronic began notifying Clinicians on 30-Aug-2018 via locally approved methods.

    Distribution

    Worldwide Distribution

    Quantity

    17,275 units