Terumo : Announces Voluntary Recall of Specific Models of the Relay™Pro Thoracic Stent-Graft System in Global Markets

TOKYO, JAPAN - July 1, 2026 - Terumo Corporation (TSE: 4543) today announced that it is conducting a voluntary recall of specific models of the Relay^TMPro Thoracic Stent-Graft System in global markets. The recall has been initiated in all markets where the affected models were distributed.

The affected products are Relay^TMPro NBS (Non-Bare Stent) models with diameters ranging from 32 mm to 46 mm. Approximately 7,000 units sold between May 2024 and March 2026 are subject to this recall. The products were distributed across North America, Latin America, Europe, the Middle East, and Asia, covering a total of 43 countries.

Prior to this announcement, the Company initiated a voluntary recall of the same models in Japan on June 1, 2026. There are no changes to the scope or content of the recall currently being conducted in Japan.

The Relay^TMPro Thoracic Stent-Graft System is a medical device designed for the endovascular treatment of thoracic aortic diseases. Four cases have been reported at medical institutions outside Japan involving the affected models. In these cases, the delivery system could not be properly separated from the deployed stent-graft, preventing the delivery system from being withdrawn from the patient's body as intended. While a direct causal relationship between the device and these events has not been established at this time, three of the four reported cases resulted in patient deaths during or following the procedure.

This issue occurs only during the separation process between the delivery system and the stent-graft. Therefore, devices that have already been successfully deployed and implanted in patients are not subject to this issue.

Shipments of the affected models outside Japan have already been suspended since March 2026. However, because the Company cannot rule out the possibility that affected products remain in the market, it has decided to voluntarily recall all affected models in all markets where they have been distributed as an additional measure to ensure patient safety.

Terumo sincerely apologizes for any inconvenience this recall may cause to patients, healthcare professionals, and other stakeholders. The Company will continue to implement necessary measures to ensure product safety and prevent recurrence.