FDA Confirms Class I Recall for Vascular Device Used by Cardiologists and Surgeons

Why It Matters

A Class I recall signals a life‑threatening defect, prompting immediate changes in clinical practice and heightened regulatory focus on endovascular device safety.

Key Takeaways

• FDA classifies Relay Pro thoracic stent graft issue as Class I recall
• Issue affects non‑bare stent models 32 mm and larger
• No mandatory return; clinicians advised to use alternatives pending fix
• Three patient deaths linked to delivery system unclasp failure
• Bolton Medical, now part of Terumo Aortic, remains manufacturer

Pulse Analysis

The thoracic aorta is a high‑risk vessel, and endovascular stent grafts have become the preferred minimally invasive solution for many aneurysms and dissections. The FDA’s recent designation of the Relay Pro Thoracic Stent Graft System as a Class I recall marks the most serious level of device action, indicating that continued use could cause severe injury or death. The recall focuses on the non‑bare stent configuration sized 32 mm and above, a segment that has shown a mechanical failure to disengage from its delivery sheath. This failure was implicated in three patient fatalities, prompting the agency to elevate the warning.

For interventional cardiologists and vascular surgeons, the immediate priority is patient safety. While the agency stopped short of ordering a full product return, it urges clinicians to consider alternative therapies—such as other commercially available thoracic grafts or open surgical repair—until the root cause is resolved. The FDA also provided bailout techniques for cases where the graft remains deployed, but these maneuvers add procedural complexity and may increase operative time. Hospitals must update their inventory controls, inform surgical teams, and document any adverse events linked to the affected devices.

The recall underscores growing regulatory scrutiny of complex endovascular devices, especially as manufacturers consolidate—Bolton Medical’s integration into Terumo Aortic exemplifies this trend. Industry analysts expect tighter post‑market surveillance and more rigorous pre‑market testing for large‑diameter grafts. For patients, the episode highlights the importance of transparent communication about device risks and the availability of alternative treatment pathways. As Terumo works to identify the design flaw, the broader market may see a temporary shift toward competing stent graft platforms, potentially reshaping supplier dynamics in the thoracic aortic repair segment.