SynCardia Systems LLC: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

Hazard

Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.

Details from the source

Reason for recall: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. Distribution: 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 Quantity: 114 units Lot/code info: All Lots/ UDI: 00858000003053

UPC codes

00858000003053

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.