In April 2026, Bolton Medical issued an urgent recall for its RelayPro Thoracic Stent-Graft System after reports of a dangerous device failure during surgery, and three patients died. If you or someone in your family was harmed during a thoracic aortic procedure involving a RelayPro device, you deserve clear information about what happened and what your options may be.

This page explains the recall, the known risks, and the steps affected patients and families can consider taking now.

What the Bolton Medical RelayPro Recall Involves

The RelayPro recall is one of the more serious medical device actions in recent memory, affecting a device used during a high-risk surgical procedure with very little margin for error. Understanding what the device is, what the FDA has said publicly, and who may be affected helps families make informed decisions about next steps.

What the RelayPro Device Is and Does

The RelayPro Thoracic Stent-Graft System is a medical device used during a procedure called TEVAR, which stands for thoracic endovascular aortic repair. Surgeons use TEVAR to treat life-threatening aortic conditions, including aneurysms, dissections, and tears, by threading a stent graft through blood vessels and deploying it inside the aorta. The RelayPro is designed to be released from a delivery system inside the body at a precise moment during the procedure.

What the FDA Early Alert Says

On April 23, 2026, Bolton Medical (a subsidiary of Terumo Aortic and Terumo Corporation) issued an urgent recall for the RelayPro Thoracic Stent-Graft System, N4 Non-Bare Stent Configuration, in sizes 32mm and above. The FDA followed with a public early alert on the RelayPro recall on April 28, 2026, a designation the agency uses for high-risk device issues still under active investigation. The FDA’s investigation into this device remains open as of publication.

Who May Be Affected

Patients who underwent a TEVAR procedure using the RelayPro system in a size 32mm or larger, N4 Non-Bare Stent Configuration, may fall within the scope of this recall. Family members of patients who died during or after such a procedure may also have grounds for legal inquiry. Anyone uncertain whether a loved one’s surgery involved a RelayPro device can request the operative report and device implant log from the treating hospital.

Potential Health Risks Linked to the Device

The defect at the center of this recall is not a minor manufacturing variation. It involves a failure that occurs at the most critical moment of the procedure, with consequences that cannot be reversed once the device fails.

The Known Device Failure

The defect involves the proximal clasp disconnecting from the outer control tube during deployment. This prevents the stent graft from releasing from the delivery system at the point in the procedure when it must be placed. There is no device-based method to correct the failure once it occurs, and there is no way to detect the defect before or during placement until the moment it fails.

Reported Injuries and Deaths

Three patient deaths had been confirmed as of the recall date: one patient died from aortic perforation, and two others died from strokes following emergency conversion from minimally invasive TEVAR to open surgical repair. Emergency conversion to open surgery is a high-risk event on its own, and these cases show the range of catastrophic outcomes that can follow a RelayPro deployment failure. Additional adverse events may be reported as the FDA investigation continues.

Why Early Action Matters

Medical device litigation involving a death or catastrophic surgical injury can require extensive documentation, including operative records, device tracking information, and hospital incident reports. Statutes of limitations, which are legal deadlines for filing a claim, vary by state and typically run two to three years from the date of injury or discovery. Acting promptly helps preserve evidence and ensures families do not inadvertently miss the window to pursue a legal claim.

What Affected Patients and Families Can Do

If you believe a RelayPro device played a role in a death or serious injury, there are concrete steps you can take now. You do not need to have all the answers before reaching out for help.

Steps to Take Now

Request all medical records from the facility where the TEVAR procedure took place, including the operative report, anesthesia records, and the device implant log. The implant log will typically identify the specific device used by the manufacturer, model, and lot number, which is the information needed to confirm whether a RelayPro device was involved. You should also preserve any written communications from the hospital or surgical team following the procedure.

Documenting Your Experience

Write down a detailed account of what happened before, during, and after the procedure while the events are still clear. Note the approximate date of the procedure, the name of the facility and surgical team, and any complications that were disclosed to you at the time. If you received a follow-up visit, discharge summary, or any written explanation of what went wrong, keep those documents in a safe place.

Speaking with an Attorney

An attorney with experience in medical device litigation can review the facts of your situation and explain whether you may have a viable legal claim. This consultation is typically free and carries no obligation. At Wagstaff & Cartmell, we review each situation individually and can help you understand your options without pressure or commitment.

Frequently Asked Questions About the RelayPro Recall

Below are answers to questions families commonly ask when they first learn about a medical device recall that may have affected a loved one. This information is general in nature and does not constitute legal advice. Every situation is different, and speaking with an attorney is the best way to understand options specific to your circumstances.

What Is the Bolton Medical RelayPro Recall?

On April 23, 2026, Bolton Medical issued an urgent recall for the RelayPro Thoracic Stent-Graft System, N4 Non-Bare Stent Configuration, in sizes 32mm and above. The recall was prompted by reports of a device defect that prevents the stent graft from deploying properly during TEVAR surgery. The FDA issued a public early alert five days later and is actively investigating.

How Many People Have Died Because of the RelayPro Defect?

Three patient deaths were confirmed as of the April 23, 2026, recall date. One patient died from aortic perforation, and two others died from strokes that followed emergency conversion from minimally invasive surgery to open aortic repair. That number may change as the FDA investigation continues and additional adverse events are reported.

What Is TEVAR and Why Is a Stent Graft Failure So Dangerous?

TEVAR is a minimally invasive procedure used to treat serious aortic conditions, including aneurysms and dissections, by deploying a stent graft through blood vessels to reinforce or seal the damaged section of the aorta. When a stent graft fails to release properly during deployment, the surgeon cannot complete the intended repair and may be forced to perform emergency open surgery, a significantly more invasive procedure with substantially higher risk. In the case of the RelayPro defect, no device-level correction is possible once the failure occurs.

How Do I Know if My Loved One’s Procedure Involved a RelayPro Device?

Request the operative report and device implant log from the hospital or surgical facility where the procedure was performed. These records typically identify the specific device used by the manufacturer, model, and configuration. Our team can assist you in understanding what to request and how to interpret what you receive.

Has a Class Action Lawsuit Been Filed for the RelayPro Recall?

As of publication in May 2026, no class action lawsuit has been publicly filed in connection with the RelayPro recall. Cases are currently being evaluated on an individual basis. This page will be updated as litigation developments occur.

How Long Do I Have to File a Lawsuit?

Statutes of limitations for medical device injury and wrongful death claims typically range from two to three years from the date of injury or the date the injury was discovered, but these deadlines vary significantly by state. Because the RelayPro recall is recent and the window to act may be shorter than it appears, speaking with an attorney as soon as possible is important. Waiting can limit your options even if you ultimately decide not to file a claim.

What Compensation May Be Available?

In cases involving serious injury or death from a defective medical device, families may be able to pursue compensation for medical expenses, lost income, loss of companionship, wrongful death damages, and, in some circumstances, punitive damages. The specific damages available depend on the facts of each case and the laws of the state where the claim is filed. An attorney can assess what may be recoverable in your particular situation.

Does It Cost Anything to Speak with an Attorney?

No. We offer free, confidential consultations with no obligation. If we take your case, we work on a contingency fee basis, which means you pay no attorney fees unless we recover compensation for you.

Contact Wagstaff & Cartmell About the RelayPro Recall

If you or a family member was harmed during a TEVAR procedure involving a Bolton Medical RelayPro Thoracic Stent-Graft device, we encourage you to reach out. Our attorneys have experience in medical device litigation and can review your situation at no cost and with no obligation.

This page provides general information only and does not constitute legal advice. Submitting a contact form or calling our office does not create an attorney-client relationship. To tell us what happened and get a free, confidential case review, contact Wagstaff & Cartmell today.