Heartware, Inc.
59 recalls on record · Latest: Dec 13, 2023
FDA Devices Moderate Dec 13, 2023
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
FDA Devices Moderate Dec 13, 2023
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
FDA Devices Moderate Dec 13, 2023
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
FDA Devices Moderate Dec 13, 2023
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
FDA Devices Moderate Dec 13, 2023
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
FDA Devices Moderate Dec 13, 2023
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
FDA Devices Moderate Dec 28, 2022
HeartWare Model 1100
FDA Devices Moderate Dec 28, 2022
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
FDA Devices Moderate Dec 28, 2022
HeartWare Model 1101
FDA Devices Moderate Dec 28, 2022
HeartWare HVAD Pump Kit, REF 1103
FDA Devices Moderate Dec 28, 2022
HeartWare HVAD Pump Kit, REF 1104
FDA Devices Critical Aug 24, 2022
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergenc…
FDA Devices Moderate May 25, 2022
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
FDA Devices Moderate Mar 16, 2022
HeartWare Ventricular Assist Device (HVAD) System
FDA Devices Moderate Sep 22, 2021
Medtronic HVAD Pump Implant Kits
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1125
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1153
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Outflow Graft, REF MCS1725OG
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Accessories, REF MCS1753AK
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Driveline Extension Cable, REF 100
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1103
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Pump Implant Kit, REF 1104
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Implant Kit, REF 1104JP
FDA Devices Critical Aug 18, 2021
HeartWare HVAD Driveline Extension Cable, REF 100US
FDA Devices Moderate Jul 21, 2021
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventric…
FDA Devices Moderate Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 1…
FDA Devices Moderate Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1100, 1101, 110…
FDA Devices Critical Apr 28, 2021
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components: HVAD Sterile Implant Kit, Model Numbers: 11…
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403…
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Monitor Data Cable, Product Number: 1575
FDA Devices Critical Apr 14, 2021
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 143…
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Alarm Adapter, Product Number: 1450
FDA Devices Critical Apr 14, 2021
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 1511IL, 1511IN…
FDA Devices Critical Feb 10, 2021
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Mod…
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
FDA Devices Critical Jun 3, 2020
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
FDA Devices Critical Mar 18, 2020
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left v…
FDA Devices Critical Mar 18, 2020
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refract…
FDA Devices Moderate Dec 19, 2018
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System (HVAD) is in…
FDA Devices Critical Oct 26, 2016
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of deat…
FDA Devices Critical Jul 20, 2016
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OUS) Produc…
FDA Devices Moderate Jul 8, 2015