Brand

Heartware, Inc. Recalls

53 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Heartware, Inc..

53Total Recalls
29Critical
436,005Units Affected
Oct 31, 2023Most Recent
All Recalls

Every Heartware, Inc. Recall

Sorted by most recent. Click any recall for full details.

53 recalls
High RiskFDA
Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Medical Implants·7,438 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Medical Implants·126 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Medical Implants·45 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Medical Implants·10,287 affected·Oct 31, 2023
High RiskFDA
Heartware, Inc.
HeartWare Model 1100
Cardiac Devices·45 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Cardiac Devices·6 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare Model 1101
Cardiac Devices·82 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1103
Cardiac Devices·5,704 affected·Nov 29, 2022
High RiskFDA
Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104
Cardiac Devices·10,320 affected·Nov 29, 2022
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Cardiac Devices·19,616 affected·Jun 28, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Cardiac Devices·667 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Cardiac Devices·0 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Cardiac Devices·510 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Cardiac Devices·59 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ Sys...
Cardiac Devices·645 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
Medtronic HVAD Pump Implant Kits
Medical Implants·11,851 affected·Aug 6, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1125
Medical Implants·4,078 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1153
Medical Implants·163 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG
Cardiac Devices·459 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK
Cardiac Devices·76 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100
Cardiac Devices·338 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1103
Medical Implants·647 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1104
Medical Implants·943 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Implant Kit, REF 1104JP
Medical Implants·63 affected·Jun 3, 2021
High RiskFDA
Heartware, Inc.
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory ...
Medical Implants·1 affected·May 28, 2021
High RiskFDA
Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 1...
Medical Implants·23,123 affected·Feb 26, 2021
High RiskFDA
Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartware HVAD pump implant kits Models 110...
Medical Implants·23,123 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, ...
Medical Devices·56,018 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Medical Devices·114,133 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Monitor Data Cable, Product Number: 1575
Medical Devices·1,337 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR,...
Medical Devices·17,992 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Alarm Adapter, Product Number: 1450
Medical Devices·418 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA, 1511CH, 1511DE, 1511GB, 15...
Medical Devices·3,283 affected·Feb 26, 2021
CriticalFDA
Heartware, Inc.
Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1...
Medical Implants·19,562 affected·Nov 19, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Medical Implants·2,614 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125
Cardiac Devices·20,147 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104
Medical Implants·2,225 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP
Medical Implants·85 affected·Apr 3, 2020
CriticalFDA
Heartware, Inc.
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refra...
Cardiac Devices·5,489 affected·Jan 23, 2020
CriticalFDA
Heartware, Inc.
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemodynamic support in patients with advan...
Cardiac Devices·5,489 affected·Jan 23, 2020
High RiskFDA
Heartware, Inc.
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare Ventricular Assist System ...
Cardiac Devices·2,031 affected·Nov 19, 2018
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at ...
Cardiac Devices·4,235 affected·Jun 8, 2016
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (US) and 1650, 1650-DE and A00035 (OU...
Cardiac Devices·18 affected·Jan 7, 2016
High RiskFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refrac...
Cardiac Devices·3,747 affected·Apr 29, 2015
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a br...
Cardiac Devices·3,747 affected·Apr 29, 2015
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,1104,1104JP and 1205. Product Usag...
Cardiac Devices·3,747 affected·Apr 29, 2015
CriticalFDA
Heartware Inc
HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. For use as a ...
Cardiac Devices·3,747 affected·Apr 29, 2015