BEUDAMED
    FDA Enforcement Class II Terminated

    HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    Recall: Z-1607-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1607-2014
    Event ID
    67684
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    HeartWare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2014
    Initiation Date
    April 16, 2014
    Classification Date
    May 14, 2014
    Termination Date
    October 3, 2016
    Address
    14400 Nw 60th Ave, Miami Lakes, FL, 33014-2807, United States

    Description

    HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - HeartWare Battery For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage ventricular heart failure.The HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    Reason

    Patients and caregivers are instructed that if a battery does not provide two hours of support or behaves unusually, that battery should no longer be used and should be replaced.

    Code Info

    Catalog# USA:1650 // OUS: 1650, 1650-DE All HeartWare Battery Serial Numbers

    Distribution

    Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia and Internationally to Canada, Dominican Republic, Australia, Belgium, Italy, Germany, New Zeland, South Afica, Japan, Venezuela, Czech Republic, France, Switzerland, Brazil, UK, Saui Arabia, Taiwan, Slovakia, Luxemburg, Hong Kong, Lebano, India, Chile, Oldenburg, Israel, Netherlands, Croatia, Egypt, Turkey, Malaysia, Norway, Greece, Spain, Lithuania, Korea, Singapore, Poland, and Argentina.

    Quantity

    32,349