ANSM Safety Information: Thoraflex Hybrid Thoracic Aorta Prosthesis

Detected March 23rd, 2026

Summary

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety alert regarding the Thoraflex Hybrid thoracic aorta prosthesis manufactured by Vascutek Ltd. Healthcare providers have been notified of a safety action implemented by the manufacturer.

View original document View source feed page

What changed

The ANSM has been informed by Vascutek Ltd. of a safety action concerning their Thoraflex Hybrid thoracic aorta prosthesis. This action is registered under ANSM reference R2608253. Healthcare facilities have received direct communication from the manufacturer regarding this safety measure, and a link to the manufacturer's letter dated March 23, 2026, is provided.

Healthcare providers receiving this notice should review the manufacturer's communication carefully to understand the specific actions required or recommended. For any questions or further details, they should contact Vascutek Ltd. directly, as indicated by the ANSM. The provided link to the manufacturer's letter offers the most detailed information on the nature of the safety action and any necessary steps.

What to do next

Review communication from Vascutek Ltd. regarding the Thoraflex Hybrid prosthesis safety action.
Contact Vascutek Ltd. directly for any questions or clarification.

Source document (simplified)

A+ A-

Information n° R2608253 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Vascutek Ltd.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608253. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Vascutek Ltd (23/03/2026)