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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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Z-0475-2024 - 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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Z-0476-2024 - STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
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2
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12/02/2023
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Heartware, Inc.
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Z-0477-2024 - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
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2
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12/02/2023
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Heartware, Inc.
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Z-0478-2024 - PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
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2
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12/02/2023
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Heartware, Inc.
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Z-0483-2024 - PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU
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2
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12/02/2023
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Heartware, Inc.
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Z-0480-2024 - 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
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2
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12/02/2023
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Heartware, Inc.
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Z-0481-2024 - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP
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2
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12/02/2023
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Heartware, Inc.
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Z-0482-2024 - HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
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2
|
12/02/2023
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Heartware, Inc.
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Z-0479-2024 - PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104
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2
|
12/02/2023
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Heartware, Inc.
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