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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 25 of 54 Results
Firm: HeartWare
 
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HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD® System Emergency Re... 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System 2 03/04/2022 Heartware, Inc.
Medtronic HVAD Pump Implant Kits 2 09/16/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1103 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1104 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1125 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Implant Kit, REF 1153 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100US 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Implant Kit, REF MCS1705PU 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK 1 08/06/2021 Heartware, Inc.
HeartWare HVAD Implant Kit, REF 1104JP 1 08/06/2021 Heartware, Inc.
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support i... 2 07/13/2021 Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Heartw... 2 04/21/2021 Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these devices: Hear... 2 04/20/2021 Heartware, Inc.
Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system componen... 1 04/16/2021 Heartware, Inc.
Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 140... 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511B... 1 04/06/2021 Heartware, Inc.
Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE 1 04/06/2021 Heartware, Inc.
 
 
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