Syncardia Systems, LLC., a Picard Medical Company, is aware of the potential for small cannula tears or hole formation in the pneumatic cannula of the temporary Total Artificial Heart (TAH-t). Certified TAH-t Centers have been notified on how to mitigate the issue. Identified cases of cannula tear have not contributed to patient death or serious injury. SynCardia is working closely with the FDA to communicate appropriate information to certified centers and corrective actions will be implemented as soon as it is completed.
If you are a currently implanted TAH-t patient and have questions, please contact your TAH-t care team.
Updates to this notification will be posted when applicable. For questions please email: recalls@Syncardia.com or call 520-396-1809.