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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 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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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
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2
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12/02/2023
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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 Batteries, Product Number 1650DE
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1
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08/18/2022
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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, 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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