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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 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
|
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
|
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, 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 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 System (HVAD)
For use as a bridge-to-cardiac transplantation in patien...
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2
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06/26/2015
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HeartWare Inc
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HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient...
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2
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06/10/2015
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HeartWare Inc
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HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit
Product Usage:
Is intended ...
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1
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05/14/2015
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HeartWare Inc
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