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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 25 of 74 Results
Firm: HeartWare
 
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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 2 12/02/2023 Heartware, Inc.
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 2 12/02/2023 Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 2 12/02/2023 Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 2 12/02/2023 Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 2 12/02/2023 Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 2 12/02/2023 Heartware, Inc.
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN 2 12/02/2023 Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP 2 12/02/2023 Heartware, Inc.
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU 2 12/02/2023 Heartware, Inc.
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Exp... 2 06/22/2023 Heartware, Inc.
HeartWare HVAD Pump Kit, REF MCS1705PU 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1205 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104JP 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104CA-CLIN 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1103 2 12/21/2022 Heartware, Inc.
HeartWare Model 1102 2 12/21/2022 Heartware, Inc.
HeartWare Model 1101 2 12/21/2022 Heartware, Inc.
HeartWare Model 1100 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104 2 12/21/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE 1 08/18/2022 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 Controller, Model Number 1420-Controller 2.0 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, Pump Implant Kit, Model Number1104 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD® System Emergency Re... 2 05/17/2022 Heartware, Inc.
 
 
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