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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 Device (HVAD) System Controller, Model Number 1420-Controller 2.0
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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, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
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2
|
05/17/2022
|
Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
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2
|
05/17/2022
|
Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
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2
|
05/17/2022
|
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 Controller, Model Number 1420
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2
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05/17/2022
|
Heartware, Inc.
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HeartWare Ventricular Assist Device (HVAD) System
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2
|
03/04/2022
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Heartware, Inc.
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Medtronic HVAD Pump Implant Kits
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2
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09/16/2021
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Heartware, Inc.
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HeartWare HVAD Pump Implant Kit, REF 1103
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1
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08/06/2021
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Heartware, Inc.
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HeartWare HVAD Pump Implant Kit, REF 1104
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1
|
08/06/2021
|
Heartware, Inc.
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HeartWare HVAD Pump Implant Kit, REF 1125
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1
|
08/06/2021
|
Heartware, Inc.
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HeartWare HVAD Pump Implant Kit, REF 1153
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1
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08/06/2021
|
Heartware, Inc.
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HeartWare HVAD Driveline Extension Cable, REF 100
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1
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08/06/2021
|
Heartware, Inc.
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HeartWare HVAD Driveline Extension Cable, REF 100US
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1
|
08/06/2021
|
Heartware, Inc.
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HeartWare HVAD Implant Kit, REF MCS1705PU
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1
|
08/06/2021
|
Heartware, Inc.
|
HeartWare HVAD Outflow Graft, REF MCS1725OG
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1
|
08/06/2021
|
Heartware, Inc.
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HeartWare HVAD Pump Accessories, REF MCS1753AK
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1
|
08/06/2021
|
Heartware, Inc.
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HeartWare HVAD Implant Kit, REF 1104JP
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1
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08/06/2021
|
Heartware, Inc.
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HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support i...
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2
|
07/13/2021
|
Heartware, Inc.
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Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Heartw...
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2
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04/21/2021
|
Heartware, Inc.
|
Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Hear...
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2
|
04/20/2021
|
Heartware, Inc.
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Instructions for Use and Patient Manual for HeartWare HVAD System. Accompanies these system componen...
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1
|
04/16/2021
|
Heartware, Inc.
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Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 140...
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1
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04/06/2021
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Heartware, Inc.
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Medtronic HVAD Packaged Monitor, Model Numbers: 1500, 1500AU, 1500DE, 1510US, 1511AR, 1511AU, 1511B...
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1
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04/06/2021
|
Heartware, Inc.
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Medtronic HVAD Battery, Product Number: 1650, 1650CA-CLIN, 1650DE
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1
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04/06/2021
|
Heartware, Inc.
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