Dive Brief:
- Terumo has recalled specific models of its RelayPro Thoracic Stent-Graft System over a problem linked to three deaths, the company said Wednesday.
- The recall is in response to reports that physicians were unable to properly separate the delivery system from the deployed stent-graft. It covers about 7,000 non-bare stent RelayPro units sold across North America, Latin America, Europe, the Middle East and Asia from May 2024 to March 2026.
- Terumo recalled the same models in Japan at the start of June. There are no changes to the scope of the recall in Japan, the company said.
Dive Insight:
The recalled RelayPro device is an endovascular treatment of thoracic aortic diseases. Physicians use the minimally invasive product to repair damaged or weakened sections of the thoracic aorta, such as tears and aneurysms. The procedure entails placing a stent-graft to reinforce the vessel and maintain blood flow.
Terumo received reports of problems in four procedures outside of Japan, its home market. In each case, physicians were unable to properly separate the delivery system from the stent-graft. The issues meant the physicians were unable to withdraw the delivery system from the body as intended.
Three of the four patients died during or after the procedure. Terumo has yet to establish a direct causal relationship between the deaths and the delivery system separation issues. Despite this, the company suspended shipments of affected models outside Japan in March.
Terumo has now recalled the products because some affected devices may remain in the global market. The recall covers non-bare stent RelayPro models with diameters ranging from 32 mm to 46 mm that were sold in 43 countries.
Bolton Medical sells RelayPro devices in the U.S. The company, which Terumo acquired for $174 million in 2017, sent RelayPro customers a correction notice in April. The Food and Drug Administration issued an early alert notice about the correction that month and categorized the action as a Class I recall in May. The notices described a delivery-system separation problem associated with three deaths.
