BEUDAMED
    FDA Enforcement Class I Terminated

    HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    Recall: Z-0005-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0005-2017
    Event ID
    72001
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heartware, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    June 8, 2016
    Classification Date
    October 17, 2016
    Termination Date
    March 31, 2020
    Address
    14400 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    Reason

    Loose connector ports in controller body.

    Code Info

    All Heartware Controllers manufactured after September 2014. US Model No: 1400, 1401XX, 1403US. International Model No: 1400, 1401XX, 1407XX.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and countries of Australia, Austria, Belgium, Canada, France, Germany, Lebanon, Malaysia, Sweden, Switzerland, & United Kingdom.

    Quantity

    4235 Worldwide, 7272 units in U.S.