medical Class II Updated 2023-11-01

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

Recalled Product

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


Hazard / Issue

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

Issued by

FDA

Affected States: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA
Lot/Code Info: All Lots/ UDI: 00858000003053
View official government recall

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