Bolton Medical has initiated a voluntary worldwide recall of its Relay Pro thoracic stent graft system after reports that affected devices may fail to unclasp from their delivery mechanism during implantation, potentially requiring emergency conversion to open surgical repair. The U.S. Food and Drug Administration (FDA) classified the recall as a Class I event—the most serious category—indicating that use or exposure to the product could cause serious injury or death.
Thoracic Stent Graft Deployment Risk Hierarchy
FDA recall classifications and associated clinical consequences, 2024
Source: FDA Medical Device Recall Classifications, 2024 | Georgian Medical Journal News
The Mechanical Failure at the Heart of the Recall
The Relay Pro system is designed to deliver a fabric-covered metal scaffold (stent graft) into the thoracic aorta to reinforce weakened arterial walls. During the procedure, the device is advanced through a catheter and must unclasp cleanly from the delivery system once positioned correctly. When this unclasp mechanism fails, the graft remains tethered to the delivery catheter, leaving the surgeon unable to proceed with standard minimally invasive technique.
According to Bolton Medical’s submission to the FDA, the failure to unclasp forces clinicians to convert to open surgical repair—a far more traumatic intervention requiring full thoracic incision, general anaesthesia, and extracorporeal circulation support. This conversion carries substantially higher morbidity and mortality compared to the intended endovascular procedure, and the FDA recall notice explicitly states the potential for patient death.
Why This Recall Matters for Vascular Surgery and Patient Safety
Thoracic aortic aneurysms affect approximately 5–10 per 100,000 people annually and represent a life-threatening condition requiring urgent intervention. Endovascular repair (using stent grafts like Relay Pro) has become the standard of care in high-risk surgical patients because it avoids the physiological stress of open surgery. When the device fails to deploy, patients face not only the original aneurysm risk but also the acute danger of emergency conversion, which prolongs operative time and increases exposure to surgical complications.
The National Library of Medicine and vascular surgery literature document that conversion to open repair during endovascular thoracic aortic repair is associated with substantially elevated mortality rates. Bolton Medical’s decision to issue a Class I recall signals acknowledgment that the risk of harm outweighs any benefit of continued distribution.
This recall also underscores the importance of robust postmarket surveillance and quality control in medical device manufacturing. Deployment failure during stent graft placement is a preventable adverse event if manufacturing tolerances are maintained and quality assurance processes detect defects before release.
Clinician and Patient Implications
Hospitals and interventional centres currently holding inventory of Relay Pro grafts have been advised to quarantine affected lots and return them to Bolton Medical. Patients scheduled for thoracic endovascular aortic repair (TEVAR) using the Relay Pro system should discuss alternative devices with their surgical teams. Several competing thoracic stent graft systems remain available, including the Zenith TX2 and Gore TAG, both with established long-term safety and efficacy data.
For patients who have already received a Relay Pro implant without incident, no urgent clinical action is required; however, close follow-up imaging and symptom monitoring remain standard postoperative care. Physicians are encouraged to report any suspected deployment failures to both Bolton Medical and the FDA MedWatch programme, which strengthens the postmarket surveillance network and informs future safety updates.
Bolton Medical initiated a worldwide Class I recall of the Relay Pro thoracic stent graft system due to reports of deployment failure that may force emergency conversion to open surgical repair, with potential for serious patient harm or death.
— U.S. Food and Drug Administration (FDA), 2024
Key takeaways
- The Relay Pro stent graft may fail to unclasp from its delivery system, rendering it unusable and forcing surgeons to convert to open surgical repair, a far more invasive procedure with higher mortality risk.
- This Class I recall is the most serious FDA classification, indicating potential for serious injury or death—highlighting the critical importance of device reliability in interventional cardiothoracic procedures.
- Affected hospitals should quarantine inventory and discuss alternative thoracic stent graft options with patients; alternative systems remain available with established safety records.
- Clinicians should report any suspected deployment failures to FDA MedWatch to strengthen postmarket surveillance and prevent future device-related adverse events.
Frequently asked questions
What is a thoracic stent graft and why is deployment failure so dangerous?
A thoracic stent graft is a fabric-covered metal tube inserted via catheter into the aorta to reinforce weakened areas and prevent rupture. Deployment failure traps the graft in the delivery system, preventing the surgeon from removing the catheter safely and forcing conversion to open surgery. Open thoracic repair carries substantially higher mortality than endovascular repair, especially in elderly or high-risk patients who initially elected the minimally invasive approach.
Should I seek immediate medical attention if I received a Relay Pro implant?
No urgent action is needed for patients who received a Relay Pro implant without incident. However, inform your vascular surgeon of this recall and ensure you maintain regular imaging follow-up and symptom monitoring as part of standard postoperative care. Contact your surgeon if you experience new chest or back pain, shortness of breath, or unexplained haemodynamic changes.
Are there alternative thoracic stent grafts I can discuss with my surgeon?
Yes. The Zenith TX2 and Gore TAG thoracic stent grafts are well-established alternatives with extensive clinical safety and durability data. Your vascular surgeon can advise which system is most appropriate based on your anatomy and clinical presentation. Hospital inventory of alternatives should be confirmed before scheduling your procedure.
The thoracic stent graft market remains robust, with multiple competing devices available and undergoing continuous refinement. This recall, while serious, reflects the FDA’s vigilant oversight of device safety and Bolton Medical’s responsibility to protect patient welfare. Vascular surgeons and patients should treat this as a reminder of the critical importance of device traceability, lot tracking, and open communication between manufacturers, regulators, and clinical centres. Stronger adherence to these principles across the medical device industry can prevent similar failures and maintain confidence in evidence-based device selection and patient safety protocols.
Source: Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
