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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 60 Results
PMA Number: P100047
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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 Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU 1 06/03/2022 Medtronic Inc
HeartWare HVAD System Battery Charger The HeartWare HVAD System is indicated for hemodynamic sup... 1 03/09/2020 Heartware, Inc.
HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System is indicated for hemod... 1 03/09/2020 Heartware, Inc.
HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use... 1 04/27/2017 Heartware
HeartWare Ventricular Assist Device (HVAD) System 2 03/04/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE 1 08/18/2022 Heartware, Inc.
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