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SynCardia Systems LLC recalls SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Recalled November 1, 2023 · FDA recall Z-0126-2024 · SynCardia Systems
Hazard
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. · FDA Class II
Units
114 units
Sold at
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
Description
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Product
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Manufacturer(s)
SynCardia Systems LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →