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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 74 Results
Firm: HeartWare
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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 Model 1101 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF MCS1705PU 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1205 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104JP 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104CA-CLIN 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1104 2 12/21/2022 Heartware, Inc.
HeartWare HVAD Pump Kit, REF 1103 2 12/21/2022 Heartware, Inc.
HeartWare Model 1102 2 12/21/2022 Heartware, Inc.
HeartWare Model 1100 2 12/21/2022 Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE 1 08/18/2022 Heartware, Inc.
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