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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P...
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2
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11/24/2009
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Thoratec Corp
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Thoratec Heartmate II Left Ventricular Assist System (LVAS). Model/Catalog Number 1355 and Model/Ca...
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2
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12/22/2008
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Thoratec Corp
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HeartMate II System Controller, a component of the HeartMate II Left Ventricular Device System (LVAS...
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2
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10/13/2010
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Thoratec Corp
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Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US, 1286C, L128...
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1
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06/07/2024
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Thoratec Corp.
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HeartMate II Left Ventricular Assist System (LVAS):
1. HeartMate II Sealed Outflow Graft with Bend ...
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1
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03/22/2024
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Thoratec Corp.
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HeartMate® II LVAS with Pocket Controller;
106015 - HMII LVAD SEALED KIT-PCTRL, NA
UDI: 008130240...
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1
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05/24/2017
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Thoratec Corporation
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HeartMate® II LVAS with Pocket Controller;
107801 - HMII PUMP & POCKET CTRL ONLY
UDI:008130240112...
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1
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05/24/2017
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Thoratec Corporation
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HeartMate® II LVAS with Pocket Controller;
106762 - HMII POCKET CONTROLLER, NA;
UDI: 008130240112...
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1
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05/24/2017
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Thoratec Corporation
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Heart Mate II Pocket Controllers removed from packaging
Product Usage: HeartMate II is a mecha...
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1
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03/21/2014
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Thoratec Corporation
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HeartMate II System Controller
Product Usage: HeartMate II is a mechanical device that circulate...
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1
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03/21/2014
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Thoratec Corporation
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