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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 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 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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Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The...
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2
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12/07/2018
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Heartware, Inc.
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Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420
P...
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2
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10/03/2018
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Heartware, Inc.
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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: 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 Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) Syst...
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1
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06/21/2022
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Medtronic Inc
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HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
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1
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06/03/2022
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Medtronic 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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Medtronic HVAD Pump Implant Kits, labeled as:
a. PUMP 1103,
b. PUMP 1104,
c. PUMP 1104JP,
d. P...
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1
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02/04/2021
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Medtronic Inc
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