Device product
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Z-0126-2024
Product summary
- Event
- Event 92930
- Status
- Completed
- Classification
- Class II
- Quantity
- 114 units
- Official record key
device-enforcement:Z-0126-2024
Official wording
Reason: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Code information: All Lots/ UDI: 00858000003053
Distribution pattern: 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
Derived failure modes
-
Unknown
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.