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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 18 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 Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate II® LVAS Implant Kit Model/Catalog Number: 106015, H... 2 11/14/2025 Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi... 1 08/13/2025 Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 ... 1 08/13/2025 Thoratec LLC
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mecha... 1 03/21/2014 Thoratec Corporation
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P... 2 11/24/2009 Thoratec Corp
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 Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend ... 1 03/22/2024 Thoratec Corp.
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