Recall Z-1022-2023— SynCardia Systems LLC

Name: FDA recall Z-1022-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-02

Class II · Ongoing

Class II FDA medical device recall by SynCardia Systems LLC, initiated 2022-11-02. FDA's recall record names no specific 510(k) clearance for this event. Product: SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000. Reason: Due to tears reported tears in the cannula due to wear and tear stress..

Recalling firm: SynCardia Systems LLC
Classification: Class II
Status: Ongoing
Initiated: 2022-11-02
Firm location: Tucson, AZ, United States

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.