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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 16 Results
PMA Number: P060040
 
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Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 ... 1 08/13/2025 Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi... 1 08/13/2025 Thoratec LLC
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Re... 1 04/17/2025 Thoratec LLC
HeartMate® II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:008130240112... 1 05/24/2017 Thoratec Corporation
HeartMate® II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 008130240112... 1 05/24/2017 Thoratec Corporation
HeartMate® II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008130240... 1 05/24/2017 Thoratec Corporation
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mecha... 1 03/21/2014 Thoratec Corporation
HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical de... 1 03/21/2014 Thoratec Corporation
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulate... 1 03/21/2014 Thoratec Corporation
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) ... 1 03/21/2014 Thoratec Corporation
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