FDA recall Z-0126-2024

Product

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

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

Key facts

Status

Completed

Initiation date

2023-08-01

Report date

2023-11-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tucson, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0126-2024