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SynCardia Systems LLC

SynCardia Systems LLC Recalls

All product recalls associated with SynCardia Systems LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Aug 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–2 of 2 recalls

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

Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

FDAAug 1, 2023AZ, CA, FL +12 more• SynCardia Systems LLC

SynCardia Systems LLC: SynCardia Total Artificial Heart System (70CC): 500101-00...

Due to tears reported tears in the cannula due to wear and tear stress.

FDANov 2, 2022Nationwide• SynCardia Systems LLC