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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 5 of 5 Results
PMA Number: P030011
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Product Description
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FDA Recall
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SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO 2 10/20/2023 SynCardia Systems LLC
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart Syste... 2 01/27/2023 SynCardia Systems LLC
5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). P... 1 12/08/2016 SynCardia Systems Inc.
Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usa... 1 09/17/2015 SynCardia Systems Inc.
Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component... 2 12/28/2012 SynCardia Systems Inc.