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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 HVAD Pump Implant Kit, Product (REF) Number 1104
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1
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05/22/2020
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Heartware, Inc.
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Heartware HVAD Pump Implant Kit, Product (REF) Number 1103
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1
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05/22/2020
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Heartware, Inc.
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Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
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1
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05/22/2020
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Heartware, Inc.
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HeartWare HVAD System Battery Charger
The HeartWare HVAD System is indicated for hemodynamic sup...
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1
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03/09/2020
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Heartware, Inc.
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HeartWare HVAD System Battery Charger AC Adapter
The HeartWare HVAD System is indicated for hemod...
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1
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03/09/2020
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Heartware, Inc.
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Heartware Medtronic HVAD System for cardiac use. Including the following parts:
(a) Controller / ...
|
1
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05/21/2018
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Heartware
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HeartWare HVAD System Controller
The HeartWare Ventricular Assist System (VAS is indicated for use...
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1
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04/27/2017
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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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04/25/2017
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Heartware
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HeartWare Ventricular Assist System Controller
Product Usage:
For use as a bridge-to-cardiac tr...
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1
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10/17/2016
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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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