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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 12 Results
PMA Number: P060040
 
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Brand Name: HeartMate Product Name: HeartMate II® Controller (standalone) Model/Catalog Number: 10... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate II® LVAS Implant Kit Model/Catalog Number: 106015, H... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Ca... 2 12/22/2008 FEI # 2916596
Thoratec Corp
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend ... 1 03/22/2024 FEI # 2916596
Thoratec Corp.
HeartMate® II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008130240... 1 05/24/2017 FEI # 2916596
Thoratec Corporation
HeartMate® II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:008130240112... 1 05/24/2017 FEI # 2916596
Thoratec Corporation
HeartMate® II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 008130240112... 1 05/24/2017 FEI # 2916596
Thoratec Corporation
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mecha... 1 03/21/2014 FEI # 2916596
Thoratec Corporation
HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical de... 1 03/21/2014 FEI # 2916596
Thoratec Corporation
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) ... 1 03/21/2014 FEI # 2916596
Thoratec Corporation
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