The FDA has classified Bolton Medical’s RelayPro Thoracic Stent Graft System as a Class I recall after 3 patient deaths were linked to a device failure during surgery.
The recall covers all Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration, 32mm and above.
This device is implanted to repair damaged or weakened sections of the thoracic aorta, including aneurysms, dissections, and tears. Bolton Medical is now part of Terumo Aortic.
The FDA issued an early alert on April 28, 2026 and upgraded the action to a Class I recall on May 20, 2026.
According to the FDA notice, “Bolton Medical has reported three deaths associated with this issue, including one aortic perforation and two conversions to open surgery which resulted in patient deaths due to stroke.”
The reason for the recall is a defect in the graft’s release mechanism. In some cases, the graft cannot unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. When this happens during surgery, the implant cannot be recaptured and there is no device-based bailout method available.
The FDA warns that the failure mode “can occur without prior warning” and is “not able to be recognized until it occurs during the procedure.” Surgeons may then be forced to convert to an open surgical repair to release the clasp. This step “can result in patient death,” according to the FDA.
Bolton Medical sent a recall letter to all affected customers on April 23, 2026 recommending that doctors “consider use of alternative stent-graft options prior to use of impacted RelayPro devices until mitigation measures are in place.” The company also told users to first attempt the existing bailout techniques in the Instructions for Use if a release problem occurs.
The RelayPro Thoracic Stent-Graft System was approved by the FDA in August 2021 under premarket approval P200045, with an expanded approval for dissection and transection added in March 2023.
Customers in the U.S. with questions about the recall are directed to contact Terumo Aortic at Market_Actions-TMC@terumomedical.com. Healthcare professionals and patients may also report adverse reactions or quality problems to the FDA’s MedWatch program.
Patients or families of patients who underwent thoracic aortic repair with a RelayPro Thoracic Stent Graft and experienced a serious complication or death may have legal options. A product liability attorney can advise on individual rights.
Source: Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System