40 results
·
9ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
×
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
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.
FDA Enforcement
Class I
·Terminated·Heartware, Inc.·July 20, 2016
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 System (HeartWare Controller) Product Usage: 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 System is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Enforcement
Class I
·Terminated·HeartWare Inc·March 4, 2015
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.
FDA Enforcement
Class I
·Terminated·HeartWare Inc·April 30, 2014
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 Controller Product Usage: 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 HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
FDA Enforcement
Class I
·Terminated·Heartware, Inc.·October 26, 2016
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 HVAD Implant Kit, REF 1104JP
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Implant Kit, REF MCS1705PU
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1125
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Driveline Extension Cable, REF 100
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1104
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Driveline Extension Cable, REF 100US
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1153
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021