Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SynCardia 50cc TAH-t Recalled by SynCardia Systems LLC Due to Artificial hearts contain a epoxy resin that has...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SynCardia Systems LLC directly.
Affected Products
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Quantity: 114 units
Why Was This Recalled?
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Where Was This Sold?
This product was distributed to 15 states: AZ, CA, FL, IL, IN, NE, NY, NC, OH, OK, PA, TX, VA, WA, WI
About SynCardia Systems LLC
SynCardia Systems LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report