BEUDAMED
    FDA Enforcement Class I Terminated

    HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.

    Recall: Z-1887-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-1887-2016
    Event ID
    73636
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Heartware, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2016
    Initiation Date
    January 7, 2016
    Classification Date
    July 8, 2016
    Termination Date
    March 27, 2020
    Address
    14400 NW 60th Ave, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Product Usage: Used as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System is designed for in-hospital and out-of-hospital settings, including transportation via fixed-wing aircraft or helicopter.

    Reason

    Heartware Ventricular Assist System Battery Cell experiencing premature depletion.

    Code Info

    Serial numbers ranging BAT000001 to BAT199999.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and Washington D.C.

    Quantity

    18, 631