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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 System Controller The HeartWare Ventricular Assist System (VAS is indicated 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 Ventricular Assist System (VAS) is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter

    FDA Enforcement
    Class I ·Ongoing·Heartware·May 3, 2017

    Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, MCS1705PU HVAD Controller Kit, Model Numbers: 1403US, 1407AU, 1407CA, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1420, 1420JP HVAD AC Adapter Controller, Model Numbers: 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US HVAD DC Adapter Controller: Model Number: 1440 HVAD DATA CABLE 1575- MONITOR, Model Number: 1575 HVAD Battery Pack, Model Numbers: 1650, 1650CA-CLIN, 1650DE HeartWare Patient Pack, Model Number: 1475 HeartWare Waist Pack, Model Numbers: 2050, 2050IL, 2050OUS HeartWare Shoulder Pack, Model Numbers: 2060, 2060IL, 2060OUS 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 I ·Ongoing·Heartware, Inc.·April 28, 2021

    HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usage: 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 I ·Ongoing·HeartWare Inc·June 17, 2015

    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). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP 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.

    FDA Enforcement
    Class I ·Ongoing·HeartWare Inc·June 24, 2015

    HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.

    FDA Enforcement
    Class I ·Ongoing·HeartWare Inc·June 17, 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

    HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.

    FDA Enforcement
    Class I ·Ongoing·Medtronic Inc·June 29, 2022

    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).

    FDA Enforcement
    Class I ·Ongoing·Heartware·May 3, 2017

    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