SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Recall date
- August 1, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0126-2024
- FDA classification
- Class II
- Brand / firm
- SynCardia Systems LLC
- Sold / distributed
- US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia
Why it was recalled
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
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