SynCardia Systems LLC FDA Recalls

2 recalls on file across devices, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EOClass IIAug 1, 2023Artificial hearts contain a epoxy resin that has not been re	Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.	Class IIDevices	Aug 1, 2023
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000Class IINov 2, 2022Due to tears reported tears in the cannula due to wear and t	Due to tears reported tears in the cannula due to wear and tear stress.	Class IIDevices	Nov 2, 2022