Relay Pro Stent Graft Recall: What Patients and Families Should Know

If a loved one had aortic surgery in the past two years, a new federal safety action may affect them. On July 17, 2026, the U.S. Food and Drug Administration updated its most serious warning about a widely used aortic implant. The Relay Pro stent graft recall now urges doctors to stop using certain devices and return them to the manufacturer.

You may be reading this because someone in your family was treated for an aneurysm or a tear in the aorta. That is frightening on its own. Learning that the device may be defective adds a new layer of worry. This article explains, in plain terms, what the recall covers, why it matters, and what steps affected patients and families can consider.

What the Relay Pro stent graft recall covers

The Relay Pro Thoracic Stent-Graft System is a device used to repair a damaged section of the thoracic aorta, the body’s largest artery. Surgeons place it through a minimally invasive procedure to reinforce a weakened or torn vessel and keep blood flowing. It is used to treat serious conditions like aneurysms and dissections.

According to the FDA, the recall applies to specific Relay Pro models with a non-bare stent configuration of 32 mm and larger. The manufacturer, Bolton Medical (part of Terumo Aortic), issued an urgent recommendation to remove these devices from where they are used or sold.

The FDA has classified this as a Class I recall, its most serious category. That designation means the agency believes continued use could cause serious injury or death.

Why the FDA escalated its warning

Because of how the problem shows up, the FDA’s guidance changed over time. Earlier notices told hospitals they could keep using the device if they understood the risk. As of July 17, 2026, the agency instead urges clinicians to stop using it immediately and return unused inventory.

The reason is the nature of the defect. Bolton Medical reported that, in some cases, the graft cannot unclasp from the delivery system during surgery. The FDA notice explains that this can prevent the surgeon from releasing the stent as intended.

As a result, the procedure may be delayed, the graft may be displaced, or the team may be forced to convert to open surgery. The manufacturer has reported that this issue has been associated with three deaths, including one aortic perforation and two conversions to open surgery that resulted in fatal strokes.

Importantly, the FDA states that this failure can happen without warning and that no reliable device-based backup fix has been identified for this specific scenario. You can read the FDA’s recall notice for the full technical details.

Who may be affected

Patients who received one of the recalled Relay Pro models during aortic repair are the most directly affected. Families of patients who died or suffered complications during or after such a procedure may also have questions.

However, a recall does not automatically mean a specific patient was harmed or that any specific claim exists. Many people who receive medical devices are never injured by them. The concern is greatest for patients who experienced a complication that a defect could plausibly explain.

If this describes your situation, a few steps can help:

• Keep your medical records. Operative reports, device stickers, and implant cards identify the exact device used.
• Ask your surgeon whether the device you or your loved one received is part of the recall.
• Write down the timeline of the procedure and any complications while the details are fresh.
• Preserve any correspondence from the hospital or manufacturer about the recall.

How defective medical device cases generally work

When a medical device is alleged to be defective, injured patients may have a product liability claim against the company that designed, made, or sold it. These cases turn on proving that the device was unreasonably dangerous and that the defect caused real harm.

To be clear, no lawsuit is guaranteed, and every case depends on its own facts. A recall is evidence a court may consider, but it is not by itself proof that any particular patient’s injury was caused by the device. That connection has to be established with medical and engineering evidence.

Because these matters involve federal safety data, complex science, and well-funded corporate defendants, they are difficult to handle alone. Deadlines to file, known as statutes of limitations, also vary by state and can be short. For that reason, it is wise to speak with a lawyer promptly rather than wait.

How Trial Lawyers United helps

Trial Lawyers United handles defective medical device claims for patients and families across the country. When a device company’s product is linked to serious harm, our job is to investigate what happened and hold the responsible company accountable.

Our approach starts with preserving evidence early: the device records, the operative notes, and the manufacturer’s own data. From there, we build the case with medical consultants and engineering experts who can explain whether a defect caused the injury.

The firm prepares every case for trial from the outset, which signals to defendants that we are not seeking a quick, discounted resolution. Trial Lawyers United maintains its principal office in Phoenix, Arizona, and works with local counsel where a case is filed in another state.

Frequently asked questions

What should I do if my family member has a recalled Relay Pro device?

First, do not panic; a recall does not mean an injury occurred. Instead, confirm with the treating surgeon whether the specific device is part of the recall, keep all medical records, and ask whether any follow-up monitoring is recommended.

Is there a lawsuit over the Relay Pro stent graft recall?

As of now, this is a newly announced recall, and litigation in this area is still developing. Because facts are still emerging, it is best to have your situation reviewed individually rather than assume a claim exists.

How long do I have to take legal action?

Deadlines vary by state and can be surprisingly short. As a result, anyone concerned about a possible defective medical device claim should consult an attorney promptly to protect their rights.

How much does it cost to talk to a lawyer?

At Trial Lawyers United, the consultation is free and confidential. The firm works on a contingency fee, which means there is no fee unless there is a recovery.

Talk to a lawyer about the Relay Pro stent graft recall

If you or someone you love was harmed after receiving a recalled aortic stent graft, you do not have to take on a device manufacturer alone. Trial Lawyers United offers a free, confidential consultation to talk through your options. Call 602-560-5170 or contact us online, and remember: there is no fee unless we win.

Attorney Advertising. This article is provided for general informational purposes only and does not constitute legal advice. Reading it does not create an attorney-client relationship with Trial Lawyers United LLC. Every case is different, laws vary by state and change over time, and past results do not guarantee or predict a similar outcome in any future matter. Trial Lawyers United LLC maintains its principal office in Phoenix, Arizona; cases in other jurisdictions are handled in association with attorneys licensed in those jurisdictions. If you have a legal question about your specific situation, please consult a licensed attorney.