BEUDAMED
    FDA Enforcement Class I Terminated

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. 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 HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    Recall: Z-1471-2014 · Reported April 30, 2014

    Enforcement

    Recall Number
    Z-1471-2014
    Event ID
    67466
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    HeartWare Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 30, 2014
    Initiation Date
    December 6, 2013
    Classification Date
    April 22, 2014
    Termination Date
    November 3, 2016
    Address
    14400 Nw 60th Ave, N/A, Miami Lakes, FL, 33014-2807, United States

    Description

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. 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 HeartWare VAS is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

    Reason

    The housing to the Pump's driveline connector became partially or fully separated from the front portion of the driveline connector.

    Code Info

    Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. Serial Numbers: HW001 to HW11270 and HW20001 to HW 20296.

    Distribution

    Worldwide Distribution - USA Nationwide in the states of MN, IL, FL, WI, MO, MA, NC, CA, GA, AL, CO, TX, OH, NY, VA, UT, KY, MD, AZ, SC, IN, PA, DE, NJ, LA, OR, WA, MI, IA, TN and DC and countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, Poland, Singapore, Slovakia, South Africa, Spain, Switzerland, Turkey and United Kingdom.

    Quantity

    4,586