31 results
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20ms
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Sources: EU EUDAMED, US FDA
HeartWare HVAD System Battery Charger AC Adapter 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.·March 18, 2020
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 HVAD System Battery Charger 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.·March 18, 2020
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 24, 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 Inc·May 20, 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), US product: Model No.: 1103; and International Product: Model No.: 1104XX. 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. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
FDA Enforcement
Class I
·Ongoing·HeartWare, Inc·October 19, 2016
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 HVAD Pump Outflow Graft, Product (REF) Number 1125
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·June 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·June 3, 2020
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·June 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·June 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·June 3, 2020
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·April 14, 2021
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN, 1511IT, 1511JP, 1511MY, 1520CLIN-AU, 1520CLIN-DE, 1520CLIN-GB, 1520JP, 1520US, 1521AU, 1521BR, 1521CA, 1521CH, 1521DE, 1521GB, 1521IL, 1521IN, 1521IT, 1521JP, 1521KR, 1521TW, 1521US, 1522CA, 1522CA-CLIN
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·April 14, 2021
HeartWare HVAD Implant Kit, REF 1104JP
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·April 14, 2021
Medtronic HVAD Monitor Data Cable, Product Number: 1575
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·April 14, 2021
Medtronic HVAD Alarm Adapter, Product Number: 1450
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·April 14, 2021
HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Enforcement
Class I
·Ongoing·Heartware, Inc.·August 18, 2021