FDA-Device2023-11-01Class II
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
SynCardia Systems LLC
Hazard
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Sold states
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
Affected count
114 units
Manufactured in
1992 E Silverlake Rd, N/A, Tucson, AZ, United States
Products
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0126-2024Don't want to check this manually?
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