SynCardia Systems LLC recalls

2 recalls on record · latest: August 1, 2023

Official U.S. recall history for SynCardia Systems LLC, compiled from official government records.

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SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

August 1, 2023 · Medical device recalls Moderate risk Artificial hearts contain a epoxy resin that has not been reviewed by the FDA f…

SynCardia Systems LLC recalls SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

November 2, 2022 · Medical device recalls Moderate risk Due to tears reported tears in the cannula due to wear and tear stress.