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Cannula Tear Potential

Syncardia Systems, LLC., a Picard Medical Company

Syncardia is working closely with the FDA to communicate appropriate information to certified centers and corrective actions

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.

About SynCardia Systems, LLC

Headquartered in Tucson, Ariz., SynCardia manufactures the world’s only commercially approved total artificial heart. In clinical use for more than 35 years and with more than 1,800 implants, the SynCardia temporary Total Artificial Heart (TAH) is the most widely used and extensively studied TAH in the world.

By partnering with, training and supporting healthcare teams at more than 140 transplant hospitals and heart failure programs in more than 20 countries, SynCardia helps create better outcomes for critically ill adults and adolescents whose best chance at survival is total heart replacement. When a donor heart isn’t an available option, SynCardia provides a new heart without the wait for patients with end-stage heart failure affecting both sides of the heart (biventricular failure).

The SynCardia temporary Total Artificial Heart (TAH-t) is a treatment option for cardiac transplant-eligible patients at risk of imminent death from biventricular failure.

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