Relay Pro Thoracic Stent Graft Wrongful Death Lawsuit Lawyers

Healthcare Providers Are Now Being Urged to Return Unused Devices Immediately Following Updated FDA Safety Guidance Involving Life-Threatening Device Malfunctions

What Parker Waichman LLP Found

• The FDA now advises healthcare providers to stop using recalled Relay Pro Thoracic Stent Grafts immediately and return all unused devices.
• The deployment malfunction may prevent the stent graft from releasing from its delivery system during surgery.
• The FDA previously designated the recall as a Class I recall, the agency’s highest risk classification.
• Federal regulators have linked the malfunction to three patient deaths.
• Patients injured by allegedly defective medical devices may have legal options under product liability laws.

The U.S. Food and Drug Administration (FDA) has issued an important update regarding certain recalled Relay Pro Thoracic Stent Grafts manufactured by Bolton Medical, now part of Terumo Aortic. After initially allowing healthcare providers to continue using certain devices with heightened precautions, federal regulators have changed their position. The FDA now advises hospitals, physicians, and healthcare facilities to stop using these devices immediately and return all unused inventory to the manufacturer.

The updated recommendation reflects growing concern over reports that the devices may fail to deploy correctly during life-saving vascular procedures. According to the FDA, the malfunction can prevent the stent graft from unclasping from its delivery system, creating dangerous complications during surgery. These failures have been associated with procedure delays, improper placement of the graft, emergency surgical intervention, and patient deaths.

Medical devices used to repair the thoracic aorta are intended to help patients facing life-threatening cardiovascular conditions. Physicians depend on these devices to function exactly as designed because even a brief delay during an endovascular procedure can dramatically increase the risk of catastrophic injury or death. When a device intended to save a patient’s life instead creates additional dangers, serious questions arise regarding product safety, quality control, manufacturing practices, and regulatory oversight.

The FDA’s latest action highlights the seriousness of these concerns and underscores the importance of removing potentially dangerous medical devices from circulation before additional patients are harmed.

What Is a Relay Pro Thoracic Stent Graft?

A thoracic stent graft is a sophisticated medical device used to treat diseases affecting the thoracic aorta, the large artery that carries oxygen-rich blood from the heart through the chest and to the rest of the body.

Patients may require a thoracic stent graft for conditions such as:

• Thoracic aortic aneurysms
• Traumatic aortic injuries
• Aortic dissections
• Other weakened or damaged sections of the thoracic aorta.

Instead of performing traditional open-heart surgery, physicians often use minimally invasive endovascular procedures to deliver the stent graft through blood vessels using a catheter system. Once positioned inside the damaged portion of the aorta, the device is deployed to reinforce the weakened vessel wall and restore normal blood flow.

These procedures require extraordinary precision. Physicians carefully navigate guidewires and delivery systems through major blood vessels before deploying the graft at the exact treatment location.

If the deployment mechanism fails during the procedure, physicians may suddenly lose the ability to safely complete the repair. Because the thoracic aorta is the body’s largest artery, complications during these procedures can become life-threatening within moments.

The Device Malfunction That Prompted the Recall

According to the FDA, the recall centers on a deployment failure involving certain Relay Pro Thoracic Stent Grafts.

Federal regulators reported that affected devices may fail to unclasp from the delivery system after reaching the intended treatment site. When this occurs, physicians may be unable to deploy the graft properly inside the patient’s aorta.

This malfunction creates several serious risks, including:

• Delays during surgery
• Incorrect positioning of the stent graft
• Stent graft displacement
• Extended anesthesia time
• Emergency conversion to open surgery
• Additional vascular injuries
• Life-threatening bleeding
• Death

Unlike many consumer product recalls, failures involving implanted cardiovascular devices occur during highly complex surgical procedures where every minute matters.

A surgeon who encounters a deployment failure may have only limited options while attempting to stabilize the patient. Additional procedures, emergency surgery, or alternative devices may become necessary under extremely stressful circumstances.

Because these procedures often involve critically ill patients with serious cardiovascular disease, even small device failures can significantly increase surgical risks.

Why the FDA Changed Its Earlier Recommendations

When the FDA first warned healthcare providers about this issue in April 2026, physicians were informed of the risks associated with the affected devices. At that time, providers were not instructed to return unused products.

Instead, hospitals could continue using certain devices if physicians understood the risks and were prepared to manage complications should deployment problems occur.

As additional safety information became available, however, regulators reassessed the overall risk presented by these devices.

The FDA has now issued significantly stronger guidance, advising healthcare facilities to:

• Stop using all affected Relay Pro Thoracic Stent Grafts immediately.
• Return all unused inventory to the manufacturer.
• Ensure affiliated facilities are informed of the updated recommendations.
• Prevent accidental future use of recalled devices.

This change reflects the FDA’s conclusion that the potential dangers outweigh any remaining benefit of continuing to use the affected inventory.

Updated recommendations from federal regulators often indicate that additional information has altered the agency’s understanding of the risks associated with a recalled medical device.

Three Patient Deaths Raise Serious Safety Concerns

According to information released by the FDA, the malfunction has been associated with three patient deaths.

Although each medical outcome depends on individual circumstances, reports of deaths connected to device failures receive the highest level of regulatory attention.

When deaths occur during procedures involving recalled medical devices, investigators typically examine numerous issues, including:

• Device design
• Manufacturing quality
• Production testing
• Deployment mechanism performance
• Complaint history
• Post-market surveillance
• Internal manufacturer communications
• Corrective actions taken after earlier reports

Medical device manufacturers have continuing obligations to monitor products after they enter the marketplace. If recurring failures begin appearing during real-world use, companies are generally expected to investigate the cause and determine whether corrective action, field safety notices, or recalls are necessary.

Patient deaths linked to alleged device malfunctions often become the subject of extensive regulatory reviews and product liability investigations.

Understanding Class I Medical Device Recalls

The FDA previously classified this recall as a Class I recall, the agency’s most serious recall category.

A Class I recall is issued when there is a reasonable probability that use of a product will cause serious adverse health consequences or death.

Not every recalled medical device receives this designation.

Class I recalls typically involve products presenting immediate risks to patient safety.

For implanted cardiovascular devices, a Class I recall signals that continued use may expose patients to unacceptable levels of danger.

Healthcare providers closely monitor Class I recalls because they often require immediate action to remove affected products from inventory and implement patient safety measures.

Potential Injuries Associated With Stent Graft Deployment Failure

Failure of a thoracic stent graft during implantation may result in numerous serious complications.

Possible injuries include:

• Aortic rupture
• Internal bleeding
• Stroke
• Reduced blood flow to vital organs
• Cardiac complications
• Organ damage
• Emergency open surgery
• Extended hospitalization
• Permanent disability
• Death

Patients who survive deployment failures may require multiple corrective procedures, prolonged rehabilitation, and ongoing cardiovascular monitoring.

Some individuals may experience permanent complications affecting mobility, neurological function, or overall cardiovascular health.

Families may also face significant financial burdens related to emergency surgery, intensive care, rehabilitation, lost income, and long-term medical treatment.

Product Liability Claims Involving Defective Medical Devices

Medical device manufacturers have a legal duty to design, manufacture, test, and market products that are reasonably safe for their intended medical use.

When implanted devices malfunction because of defects, injured patients may have legal rights under product liability laws.

Potential legal claims may involve:

Defective Design

A design defect claim examines whether the device’s overall engineering created unnecessary risks during deployment or implantation.

Manufacturing Defects

Some recalls involve problems affecting specific production lots resulting from manufacturing errors, defective components, or quality-control failures.

Failure to Warn

Manufacturers may also face allegations that physicians or hospitals were not provided adequate warnings regarding known deployment risks or malfunction rates.

Negligence

Investigations frequently examine whether manufacturers acted reasonably when testing products, evaluating complaints, monitoring adverse events, and responding to known safety concerns.

Each case depends upon the specific facts, medical records, device identification, surgical reports, and regulatory findings.

What Patients Should Know if They Received a Relay Pro Thoracic Stent Graft

Patients should not assume their implanted device is defective solely because a recall has been issued. Many recalled medical devices continue functioning normally.

However, patients who know they received a Relay Pro Thoracic Stent Graft may wish to discuss the recall with their treating physician.

Important questions may include:

• Was my device included in the recall?
• Has my physician identified any complications?
• Do I require additional monitoring?
• Should imaging studies be performed?
• What symptoms should I report immediately?

Patients should never attempt to make medical decisions without consulting their healthcare provider.

Individuals who experienced unexpected complications during implantation, emergency surgery, prolonged hospitalization, or serious injuries following placement of a recalled device may also wish to preserve their medical records and device information while evaluating their legal rights.

Relay Pro Thoracic Stent Graft Death Lawsuit FAQs

Can I file a lawsuit if I was injured by a recalled Relay Pro Thoracic Stent Graft?

Possibly. If you suffered complications that were caused by an allegedly defective Relay Pro Thoracic Stent Graft, you may have grounds to pursue a product liability claim. An attorney can review your medical records, surgical reports, and the specific device implanted to determine whether the recall may be connected to your injuries.

Does a Class I recall automatically mean I have a lawsuit?

No. A Class I recall does not automatically create a legal claim. However, it is significant evidence that the FDA determined there is a reasonable probability that the product could cause serious injury or death. Whether you have a lawsuit depends on whether the recalled device caused harm in your particular case.

What compensation may be available in a defective medical device lawsuit?

Depending on the facts, compensation may include medical expenses, future healthcare costs, lost income, diminished earning capacity, pain and suffering, disability, rehabilitation expenses, and other damages. In wrongful death cases, certain surviving family members may also be entitled to pursue damages under applicable state law.

What evidence is important in these cases?

Medical records, operative reports, imaging studies, device identification numbers, hospital records, physician notes, and documentation identifying the implanted device are often essential pieces of evidence. These records can help determine whether the recalled device was involved and whether it contributed to the patient’s injuries.

Should I have my implanted stent graft removed because of the recall?

Patients should never decide to remove or replace an implanted medical device without first consulting their treating physician. Many recalled devices continue functioning without complications, and removal surgery may involve its own risks. Your healthcare provider can evaluate your condition and determine whether additional monitoring or treatment is appropriate.

Can families pursue legal action if a recalled medical device contributed to a patient’s death?

In some situations, yes. If evidence shows that a defective medical device contributed to a fatal outcome, surviving family members may have the right to pursue a wrongful death claim, depending on the laws of the applicable state and the facts surrounding the case.

Contact Parker Waichman LLP For A Free Case Review

Patients trust that implanted medical devices have been carefully designed, tested, and manufactured for safe use. When an allegedly defective device fails during a life-saving procedure, the consequences can be devastating for patients and their families.

Parker Waichman LLP represents individuals nationwide who have suffered serious injuries linked to defective medical devices, dangerous implants, and recalled healthcare products. If you or a loved one experienced complications following implantation of a recalled Relay Pro Thoracic Stent Graft, you may have legal rights worth investigating.

Parker Waichman LLP offers free consultations to help injured patients understand their legal options. Call 1-800-YOUR-LAWYER (1-800-968-7529) today to discuss your potential claim. Regardless of your location or where your injury occurred, our nationwide product injury law firm is ready to assist you.