Published by Next Review: June 28, 2026
Table Of Contents
- Key Facts
- Latest News & Updates
- What Is the Bolton Medical RelayPro System?
- Reported Risks or Injuries
- How Does the Problem Occur?
- Who May Be Affected?
- Who May Be Liable?
- Do I Qualify?
- Important Legal Actions or Recalls
- Potential Compensation
- Legal Process Overview
- Frequently Asked Questions
- References
Key Facts
- The FDA classified the RelayPro recall as a Class I recall on May 20, 2026.
- The affected products include Relay Pro Thoracic Stent Graft System, N4: Non-Bare Stent Configuration 32mm and above.
- The FDA first issued an Early Alert about the device issue on April 28, 2026.
- The graft may be unable to unclasp from the delivery system during a procedure.
- The failure may cause procedure delays, stent graft displacement, or inability to release the graft.
- Bolton Medical reported three deaths associated with this issue as of April 23, 2026.
Latest News & Updates
May 2026
The FDA updated its communication to state that the Bolton Medical RelayPro issue had been classified as a Class I recall, meaning use of the affected device may cause serious injury or death. The recall involves removal or correction of certain RelayPro Thoracic Stent Graft System devices, and customers were advised to consider alternative stent-graft options before using impacted devices [1].
What Is the Bolton Medical RelayPro System?
The RelayPro Thoracic Stent-Graft System is a minimally invasive medical device used to treat damaged or weakened sections of the thoracic aorta. These conditions may include aneurysms, dissections, or tears.
The device is designed to place a stent graft inside the vessel to reinforce the aorta and help maintain blood flow. Because the device is used in high-risk vascular procedures, a failure during deployment can create urgent surgical complications.
Reported Risks or Injuries
- Failure to release the proximal stent
- Delay of procedure
- Stent graft displacement
- Conversion to open surgical repair
- Aortic perforation
- Stroke or death
How Does the Problem Occur?
The FDA communication states that, in some cases, the graft may be unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. The issue may be recognized during a procedure when no resistance is felt while sliding the apex holder back and the proximal stent fails to release.
At that point, the implant cannot be recaptured. The FDA also stated that this failure mode cannot be recognized before it occurs during the procedure, and no device-based bailout method has been identified for this specific scenario.
Who May Be Affected?
- Patients treated with impacted RelayPro thoracic stent graft devices
- Patients who experienced delayed procedures, open surgical conversion, stroke, or vascular injury
- Families of patients who died after a RelayPro deployment failure
Who May Be Liable?
- Bolton Medical, the device company identified in the FDA recall communication
- Manufacturers, designers, or quality-control entities, if supported by the evidence
- Hospitals or medical providers, only where case-specific facts support a separate claim
- Other parties involved in warnings, training, distribution, or device safety reporting
Do I Qualify?
- Did you or a family member receive a RelayPro thoracic stent graft?
- Was the device N4 Non-Bare Stent Configuration 32mm or above?
- Did the graft fail to release during surgery?
- Was conversion to open surgery required?
- Did the patient suffer stroke, aortic perforation, death, or other serious injury?
- Do you have operative records, implant records, hospital bills, or medical documentation?
Important Legal Actions or Recalls
| Event | Year | Type | Status | Notes |
|---|---|---|---|---|
| Bolton Medical RelayPro Thoracic Stent Graft Recall | 2026 | FDA Class I Recall | Correction / Removal | Three deaths reported in connection with graft release failure |
Potential Compensation
- Medical bills and hospitalization costs
- Revision surgery or open surgical repair costs
- Lost wages or reduced earning capacity
- Pain and suffering
- Wrongful death damages for surviving family members
Results vary. Past outcomes do not guarantee future results.
Legal Process Overview
- Consultation: A legal team reviews the implant records, procedure details, and outcome.
- Investigation: Operative reports, hospital records, device identifiers, and FDA recall materials are gathered.
- Filing: A claim may be filed if the evidence supports liability and damages.
- Discovery: The parties exchange evidence about design, warnings, deployment failures, and adverse events.
- Resolution: The case may resolve through settlement or further litigation.
Frequently Asked Questions
Q: What Bolton Medical device was recalled?
A: The recall involves the RelayPro Thoracic Stent Graft System, N4 Non-Bare Stent Configuration 32mm and above.
Q: Why was the RelayPro system recalled?
A: It was recalled because the graft may fail to unclasp from the delivery system during a procedure.
Q: Is this a Class I recall?
A: Yes. The FDA classified the recall as Class I, the most serious recall category.
Q: Were deaths reported?
A: Yes. Bolton Medical reported three deaths associated with the issue as of April 23, 2026.
Q: What should patients do?
A: Patients should speak with their treating physician about their implant history, symptoms, and whether any follow-up is needed.
Q: Can families file a lawsuit after a RelayPro death?
A: A family may have a claim if medical records show that a RelayPro deployment failure contributed to serious injury or death.
References
- https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/thoracic-stent-graft-recall-bolton-medical-removes-relay-pro-system
- https://www.fda.gov/medical-devices/medical-device-recalls/what-medical-device-recall
- https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program