BEUDAMED
    FDA Enforcement Class I Ongoing

    Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

    Recall: Z-2058-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2058-2020
    Event ID
    85397
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heartware, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    April 3, 2020
    Classification Date
    May 22, 2020
    Address
    14400 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

    Reason

    The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

    Code Info

    All lots and serial numbers in distribution

    Distribution

    Worldwide Distribution

    Quantity

    20147 devices