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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 System (HVAD).
Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, ...
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1
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06/11/2015
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HeartWare Inc
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HeartWare Ventricular Assist System (HVAD).
Catalog #'s US: 1101 and 1103 / OUS: 1100, 1101,1102,11...
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1
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06/08/2015
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HeartWare Inc
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HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product:...
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1
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10/13/2016
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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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04/25/2017
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Heartware
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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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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)
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 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, 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, 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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