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U.S. Department of Health and Human Services

Medical Device Recalls
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Product Description
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Recall
Class
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FDA Recall
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Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. 2 12/02/2023 Atrium Medical Corporation
PUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number MCS1705PU 2 12/02/2023 Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205 2 12/02/2023 Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104 2 12/02/2023 Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100 2 12/02/2023 Heartware, Inc.
STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101 2 12/02/2023 Heartware, Inc.
HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 2 12/02/2023 Heartware, Inc.
PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103 2 12/02/2023 Heartware, Inc.
1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN 2 12/02/2023 Heartware, Inc.
PUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number 1104JP 2 12/02/2023 Heartware, Inc.

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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