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On April 28, 2026, the FDA issued an Early Alert notifying the public of a potentially high-risk issue with the RelayPro Thoracic Stent-Graft System. On May 20, 2026, the FDA updated its communication to formally classify the issue as a Class I Recall — meaning the device may cause serious injury or death [1]. Bolton Medical sent an Urgent Medical Device Recall notice to all affected customers on April 23, 2026.
What Products Are Affected?
The recall covers the RelayPro Thoracic Stent-Graft System, Non-Bare Stent (N4) Configuration, in sizes 32mm and above. The RelayPro is a minimally invasive medical device used to repair damaged or weakened sections of the thoracic aorta, including aortic aneurysms, dissections, and tears, by placing a stent graft that reinforces the vessel and maintains blood flow.
What Is the Hazard?
In some cases, the RelayPro stent graft cannot be released from its delivery system during the implant procedure. This occurs because the proximal clasp disconnects from the outer control tube, preventing the graft from unclasping and deploying properly.
The failure cannot be detected until it occurs during the procedure and there is no device-based bailout method available once it happens. Surgeons may be forced to convert the minimally invasive procedure to open surgical repair, dramatically increasing the risks to the patient.
Incidents and Injuries
As of April 23, 2026, Bolton Medical has reported three deaths associated with this device failure. The fatalities include one patient who suffered an aortic perforation and two patients who underwent emergency conversion to open surgery and subsequently died from stroke.
What Caused the Recall?
The defect involves the proximal clasp of the stent graft becoming disconnected from the outer control tube of the delivery system. When this happens, surgeons lose the ability to release the proximal stent, and the implant cannot be recaptured at that stage of the procedure.
Critically, there is no warning sign that this failure will occur — and once it does, no device-based solution exists. Clinical judgment, including the decision to convert to open surgery, becomes the only available course of action.
What Should Healthcare Providers Do?
Bolton Medical has recommended that healthcare providers consider using alternative stent-graft options prior to using affected RelayPro devices until mitigation measures are in place. Providers should also review the existing bailout methods in the device’s instructions for use before any procedure involving the affected devices.
Providers with questions or to report adverse reactions should contact Terumo Aortic at Market_Actions-TMC@terumomedical.com. Healthcare professionals and patients may also report adverse events to the FDA’s MedWatch program at 1-800-332-1088.
Can I File a Lawsuit?
Patients who were implanted with the recalled RelayPro Thoracic Stent-Graft System — or families of patients who died following a device failure — may have significant legal options. A class action lawsuit or individual claim could allow affected individuals to seek compensation for medical expenses, pain and suffering, wrongful death, and other related losses. Contact an attorney as soon as possible to learn more about your rights.
References
1. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/thoracic-stent-graft-recall-bolton-medical-removes-relay-pro-system