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    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·April 28, 2021

    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU. Heartware HVAD controller kits Models 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, and 1420JP. Heartware HVAD controller AC adapter Models 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, and 1430US. Heartware HVAD controller DC Adapter Model 1440. Heartware HVAD data cable - monitor Model 1575. Heartware HVAD battery pack Models 1650, 1650CA-CLIN, and 1650DE. Heartware HVAD patient pack Model 1475. Heartware HVAD waist pack Models 2050, 2050IL, and 2050US. Heartware HVAD shoulder pack Models 2060, 2060IL, and 2060US.

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·April 28, 2021

    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.

    FDA Enforcement
    Class II ·Terminated·HeartWare Inc·May 21, 2014

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    FDA Enforcement
    Class II ·Terminated·HeartWare Inc·August 7, 2013

    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)

    FDA Enforcement
    Class II ·Terminated·Heartware Inc·May 22, 2013

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

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·May 25, 2022

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    FDA Enforcement
    Class II ·Ongoing·HeartWare Inc·July 8, 2015

    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.

    FDA Enforcement
    Class II ·Ongoing·HeartWare Inc·June 17, 2015

    Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

    FDA Enforcement
    Class II ·Terminated·Heartware, Inc.·October 10, 2018

    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·May 25, 2022

    HeartWare Model 1102

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare Model 1100

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare Model 1101

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1103

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1104JP

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF MCS1705PU

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1104

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare HVAD Pump Kit, REF 1205

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022

    HeartWare Ventricular Assist Device (HVAD) System

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·March 16, 2022

    HeartWare HVAD Pump Kit, REF 1104CA-CLIN

    FDA Enforcement
    Class II ·Ongoing·Heartware, Inc.·December 28, 2022