Reported Nov 1, 2023 · Completed
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
SynCardia Systems LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SynCardia Systems LLC · 1992 E Silverlake Rd · Tucson, AZ · 85713-3865
Is this the product you have?
- SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
- Lot codes and dates
- All Lots/ UDI00858000003053
- Amount recalled
- 114 units
Where it was sold
Why it was recalled
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
This product could cause temporary or reversible health problems — stop using it.
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