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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 60 Results
PMA Number: P100047
 
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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 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 Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE 1 08/18/2022 Heartware, Inc.
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) Syst... 1 06/21/2022 Medtronic Inc
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU 1 06/03/2022 Medtronic 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 Controller, Model Number 1407DE Kit 2 05/17/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104 2 05/17/2022 Heartware, Inc.
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