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U.S. Department of Health and Human Services

Medical Device Recalls
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21 to 30 of 60 Results
PMA Number: P100047
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Product Description
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Recall
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FDA Recall
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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 1407DE Kit 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 Implant Kit, REF 1104JP 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 Pump Implant Kit, REF 1125 1 08/06/2021 Heartware, Inc.
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