Heartware, Inc.
Miami Lakes, FL
This page shows every FDA and USDA recall linked to Heartware, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
72
Total Recalls
0013
First Recall
2023
Most Recent
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
Dec 2, 2023
· Device
Open, Classified
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
Dec 2, 2023
· Device
Open, Classified
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
Dec 2, 2023
· Device
Open, Classified
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Dec 2, 2023
· Device
Open, Classified
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
Dec 2, 2023
· Device
Open, Classified
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
Dec 2, 2023
· Device
Open, Classified
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
Dec 2, 2023
· Device
Open, Classified
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
Dec 2, 2023
· Device
Open, Classified
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
Dec 2, 2023
· Device
Open, Classified
HeartWare Ventricular Assist Device System.
a) Monitor 1521US Explore Tech,
b) Monitor 1521GB Explore Tech,...
Jun 22, 2023
· Device
Open, Classified
HeartWare HVAD Pump Kit, REF 1104CA-CLIN
Dec 21, 2022
· Device
Open, Classified
HeartWare HVAD Pump Kit, REF 1205
Dec 21, 2022
· Device
Open, Classified
HeartWare Model 1100
Dec 21, 2022
· Device
Open, Classified
HeartWare HVAD Pump Kit, REF 1103
Dec 21, 2022
· Device
Open, Classified
HeartWare HVAD Pump Kit, REF 1104
Dec 21, 2022
· Device
Open, Classified
HeartWare HVAD Pump Kit, REF 1104JP
Dec 21, 2022
· Device
Open, Classified
HeartWare Model 1102
Dec 21, 2022
· Device
Open, Classified
HeartWare HVAD Pump Kit, REF MCS1705PU
Dec 21, 2022
· Device
Open, Classified
HeartWare Model 1101
Dec 21, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Aug 18, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Mar 30, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Mar 30, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
Mar 30, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Mar 30, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Mar 30, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets:
HVAD System Emergency Responder Guid...
Mar 30, 2022
· Device
Open, Classified
HeartWare Ventricular Assist Device (HVAD) System
Jan 27, 2022
· Device
Open, Classified
Medtronic HVAD Pump Implant Kits
Aug 6, 2021
· Device
Open, Classified
HeartWare HVAD Pump Implant Kit, REF 1153
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Outflow Graft, REF MCS1725OG
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Pump Accessories, REF MCS1753AK
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Implant Kit, REF MCS1705PU
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Pump Implant Kit, REF 1103
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Pump Implant Kit, REF 1104
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Pump Implant Kit, REF 1125
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Driveline Extension Cable, REF 100US
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Implant Kit, REF 1104JP
Jun 3, 2021
· Device
Open, Classified
HeartWare HVAD Driveline Extension Cable, REF 100
Jun 3, 2021
· Device
Open, Classified
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients...
May 28, 2021
· Device
Open, Classified
Medtronic HVAD Alarm Adapter, Product Number: 1450
Feb 26, 2021
· Device
Open, Classified
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
Feb 26, 2021
· Device
Open, Classified
Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 1425GB, 1425...
Feb 26, 2021
· Device
Open, Classified
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401I...
Feb 26, 2021
· Device
Open, Classified
Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Heartware HVAD...
Feb 26, 2021
· Device
Open, Classified
Medtronic HVAD Monitor Data Cable, Product Number: 1575
Feb 26, 2021
· Device
Open, Classified
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511BR, 1511CA,...
Feb 26, 2021
· Device
Open, Classified
Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Heartware HVAD p...
Feb 26, 2021
· Device
Open, Classified
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system components:
HVAD...
Feb 26, 2021
· Device
Open, Classified
Medtronic HVAD Pump Implant Kits, labeled as:
a. PUMP 1103,
b. PUMP 1104,
c. PUMP 1104JP,
d. PUMP 1100,...
Feb 4, 2021
· Device
Open, Classified
Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
Apr 3, 2020
· Device
Open, Classified