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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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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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STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
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2
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12/02/2023
|
Heartware, Inc.
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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
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2
|
12/02/2023
|
Heartware, Inc.
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PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
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2
|
12/02/2023
|
Heartware, Inc.
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HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
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2
|
12/02/2023
|
Heartware, Inc.
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PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
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2
|
12/02/2023
|
Heartware, Inc.
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1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
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2
|
12/02/2023
|
Heartware, Inc.
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PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
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2
|
12/02/2023
|
Heartware, Inc.
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PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
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2
|
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
|
06/22/2023
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Heartware, Inc.
|