Overview of recall records associated with SynCardia Systems LLC, including dates, categories and classifications where available.
Classification mix: Class II: 2.
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Due to tears reported tears in the cannula due to wear and tear stress.
This page summarizes recall records in which the official source identifies SynCardia Systems LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
