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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 7 of 7 Results
Date Classified to: 04/24/2014 PMA Number: P060040
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Product Description
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Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Ca... 2 Dec-22-2008 Thoratec Corp
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P... 2 Nov-24-2009 Thoratec Corp
HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS... 2 Oct-13-2010 Thoratec Corp
HeartMate II Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Bend Relief. The Seal... 1 Mar-23-2012 Thoratec Corporation
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) ... 1 Mar-21-2014 Thoratec Corporation
HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulate... 1 Mar-21-2014 Thoratec Corporation
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mecha... 1 Mar-21-2014 Thoratec Corporation
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