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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 19 of 19 Results
PMA Number: P160054
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HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Outflow Graft with Bend Re... 1 03/22/2024 FEI # 2916596
Thoratec Corp.
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 ... 1 08/13/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi... 1 08/13/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US ... 2 06/18/2026 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog ... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog ... 2 06/18/2026 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 1065... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128... 2 06/18/2026 FEI # 2916596
Thoratec LLC
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Renta... 1 02/02/2024 FEI # 2916596
Thoratec Corp.
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