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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, REF 1125
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1
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08/06/2021
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FEI # 3007042319 Heartware, Inc.
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HeartWare HVAD Pump Implant Kit, REF 1104
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1
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08/06/2021
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FEI # 3007042319 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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FEI # 3007042319 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
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07/13/2021
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FEI # 3007042319 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
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FEI # 3007042319 Heartware, Inc.
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Instructions for Use and Patient Manual for HeartWare HVAD System.
Accompanies these devices:
Hear...
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2
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04/20/2021
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FEI # 3007042319 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
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04/16/2021
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FEI # 3007042319 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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FEI # 3007042319 Heartware, Inc.
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Power Supply: 1. Medtronic HVAD Controller AC Adapter, Product Numbers: 1425AU, 1425CA, 1425DE, 14...
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1
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04/06/2021
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FEI # 3007042319 Heartware, Inc.
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Medtronic HVAD Alarm Adapter, Product Number: 1450
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1
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04/06/2021
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FEI # 3007042319 Heartware, Inc.
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