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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: HeartWare Battery, Lithium Ion, 14.8 V, Rx only. Catalog 1650 (...
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1
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07/08/2016
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Heartware, Inc.
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HeartWare Ventricular Assist System (HVAD).
Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1...
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1
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06/13/2015
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HeartWare Inc
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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) 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 (HeartWare Controller)
Product Usage:
For use as a bridge-to...
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1
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02/25/2015
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HeartWare Inc
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Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101,...
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1
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04/23/2014
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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 HVAD Pump Kit, REF 1104JP
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2
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12/21/2022
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Heartware, Inc.
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HeartWare HVAD Pump Kit, REF MCS1705PU
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2
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12/21/2022
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Heartware, Inc.
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