SynCardia Systems LLC: Medical Device Recall in 2023 - (Recall #: Z-0126-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 1, 2023

Date Posted: November 1, 2023

Recall Number: Z-0126-2024

Event ID: 92930

Reason for Recall:

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

Status: Completed

Product Quantity: 114 units

Code Information:

All Lots/ UDI: 00858000003053

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated