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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 13 of 13 Results
PMA Number: P060040
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Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L128... 1 06/07/2024 Thoratec Corp.
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend ... 1 03/22/2024 Thoratec Corp.
HeartMate® II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 008130240... 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; 107801 - HMII PUMP & POCKET CTRL ONLY UDI:008130240112... 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 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
HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical de... 1 03/21/2014 Thoratec Corporation
HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Seal... 1 03/23/2012 Thoratec Corporation
HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS... 2 10/13/2010 Thoratec Corp
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P... 2 11/24/2009 Thoratec Corp
Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Ca... 2 12/22/2008 Thoratec Corp
 
 
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