SynCardia Systems LLC: Medical Device Recall in 2023 - (Recall #: Z-1022-2023)

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 Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

Product Classification:

Class II

Date Initiated: November 2, 2022

Date Posted: February 8, 2023

Recall Number: Z-1022-2023

Event ID: 91330

Reason for Recall:

Due to tears reported tears in the cannula due to wear and tear stress.

Status: Ongoing

Product Quantity: 1,732 systems

Code Information:

SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000

Distribution Pattern:

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated