Affected products include the Relay Pro NBS (non-bare stent) models with diameters ranging from 32 mm to 46 mm. The recall spans approximately 7,000 affected units sold between May 2024 and March 2026. Tokyo-based Terumo said distribution of these devices reached North America, Latin America, Europe, the Middle East and Asia. In total, the recall affects products in 43 countries.
Prior to this announcement, the company initiated a voluntary recall of the same models in Japan on June 1, 2026. Today, it says it made no changes to the scope or content of the recall in Japan.
Terumo designed the Relay Pro thoracic stent graft for the endovascular treatment of thoracic aortic diseases. The issue causing the updated recall centers around four cases reported at medical institutions outside Japan involving affected models. In these cases, the delivery system failed to properly separate from the deployed stent graft. This prevents the delivery system from being withdrawn from the patient’s body as intended.
According to Terumo, it has not yet established a direct relationship between the device and adverse events, but three of the four reported cases resulted in patient deaths during or following the procedure.
The issue only occurs during the separation process between delivery system and stent graft. Already-deployed devices are not subject to the recall.
Terumo suspended shipments of affected models outside Japan beginning in March.
“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,” the company said in a news release.
