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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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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
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2
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12/02/2023
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Heartware, Inc.
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HeartWare Ventricular Assist Device System.
a) Monitor 1521US Explore Tech,
b) Monitor 1521GB Exp...
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2
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06/22/2023
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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, 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 Controller, Model Number 1420-Controller 2.0
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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, 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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Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assi...
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2
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05/17/2022
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Medtronic 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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