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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets:
HVAD® System Emergency Re...
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2
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05/17/2022
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Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
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2
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05/17/2022
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Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
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2
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05/17/2022
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Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
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2
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05/17/2022
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Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
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2
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05/17/2022
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Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System
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2
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03/04/2022
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Heartware, Inc.
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Medtronic HVAD Pump Implant Kits
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2
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09/16/2021
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Heartware, Inc.
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HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support i...
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2
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07/13/2021
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Heartware, Inc.
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Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Heartw...
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2
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04/21/2021
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Heartware, Inc.
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Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Hear...
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2
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04/20/2021
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Heartware, Inc.
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