SynCardia Artificial Hearts Recalled for Unapproved Epoxy Resin
SynCardia Systems is recalling 114 units of the SynCardia 50cc TAH-t artificial heart because it contains an epoxy resin that has not been reviewed by the FDA for safety and efficacy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for regulatory concern: epoxy resin component lacks FDA review for safety and efficacy. No illnesses or injuries reported. Hazard is regulatory and material-based rather than based on confirmed adverse events.
Plain-English summary
SynCardia Systems LLC is recalling 114 units of the SynCardia 50cc TAH-t Total Artificial Heart (Clinical, Reference 570500, Sterile EO). The device UDI is 00858000003053.
The recall was issued because the artificial hearts contain an epoxy resin component that has not been reviewed by the FDA for safety and efficacy.
The affected devices have been distributed in the United States in Florida, Wisconsin, Arizona, Texas, California, Ohio, North Carolina, Indiana, Oklahoma, Illinois, Virginia, New York, Nebraska, Pennsylvania, and Washington. Internationally, the devices were distributed to Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia, and Australia.
The recalled product
- Product
- SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Manufacturer
- SynCardia Systems LLC
- Affected units
- 114
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots/ UDI: 00858000003053
Distribution
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