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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
Recall Date to: 08/20/2014 PMA Number: P060040
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HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) ... 1 03/21/2014 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 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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