BEUDAMED
    FDA Enforcement Class II Ongoing

    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

    Recall: Z-1106-2022 · Reported May 25, 2022

    Enforcement

    Recall Number
    Z-1106-2022
    Event ID
    90079
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Heartware, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 25, 2022
    Initiation Date
    March 30, 2022
    Classification Date
    May 17, 2022
    Address
    14400 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH

    Reason

    Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

    Code Info

    GTIN 00888707002868, Serial Numbers: MON200197, MON200321, MON200668, MON200764

    Distribution

    Finland and Turkey

    Quantity

    N/A