🔴 Safety Alert
Bolton Medical has initiated a recall of its Relay Pro thoracic stent graft system due to a critical deployment mechanism failure, according to the U.S. Food and Drug Administration (FDA) alert. The device may fail to unclasp from its delivery system during implantation, potentially forcing surgeons to convert to open surgical repair and creating risk of patient death.
Key takeaways
- Relay Pro stent grafts may fail to release from the delivery catheter, complicating or preventing successful endovascular repair
- Deployment failure may necessitate emergency conversion to open surgical repair, increasing morbidity and mortality risk
- Bolton Medical has voluntarily removed the product from market; clinicians should verify device lot numbers before use
- The FDA classifies this as a Quality & Safety issue requiring immediate institutional review
Thoracic Stent Graft Deployment Failure: Clinical Implications
Risk stratification for Relay Pro affected units
Source: FDA Medical Device Recall Alert, 2024 | Georgian Medical Journal News
Critical Deployment Mechanism Defect
The FDA alert specifies that affected Relay Pro grafts may not unclasp from their delivery system, a mechanical failure that prevents successful device deployment during endovascular repair of thoracic aortic pathology. This failure mode creates an intraoperative emergency requiring immediate clinical decision-making under duress.
When a stent graft remains attached to its delivery catheter, the surgical team cannot complete the minimally invasive procedure as planned. The device cannot be properly positioned or secured within the aorta, leaving the underlying pathology (such as aortic aneurysm or dissection) unrepaired. Withdrawal of the entrapped graft may cause vessel injury or thrombosis.
Surgical Conversion and Patient Mortality Risk
Conversion to open surgical repair—the alternative when endovascular deployment fails—represents a dramatic escalation in operative morbidity and mortality. Open thoracic aortic surgery carries substantially higher rates of spinal cord ischemia, renal failure, and in-hospital mortality compared to planned endovascular repair, particularly in elderly or medically fragile patients who are typically selected for minimally invasive approaches.
According to the FDA safety communication, the deployment failure can result in patient death. This underscores the gravity of the mechanical defect and the urgent need for hospital inventory verification and procedure postponement pending device replacement.
Immediate Clinical Actions Required
Bolton Medical has voluntarily removed the Relay Pro system from the market. Vascular surgery and interventional radiology teams should immediately identify and quarantine all affected units by lot number, verify inventory against recall communications, and halt use until replacement devices are secured.
Patients with scheduled thoracic endovascular aortic repair (TEVAR) procedures using Relay Pro should be contacted urgently to reschedule with an alternative approved device. For emergent aortic pathology, open surgical repair or alternative endograft systems should be considered. Healthcare facilities should file incident reports and safety reviews documenting any prior deployment failures that may have been attributed to other causes.
Relay Pro thoracic stent grafts may fail to unclasp from the delivery system during implantation, potentially requiring conversion to open surgical repair and resulting in patient death.
— U.S. Food and Drug Administration, Medical Device Recall Alert, 2024
What this means
Frequently asked questions
What is the Relay Pro thoracic stent graft and what was it used for?
The Relay Pro is an endovascular stent graft system designed to repair thoracic aortic aneurysms, dissections, and other pathology through minimally invasive catheter-based deployment rather than open surgery. It is positioned within the affected aortic segment to exclude the diseased area from blood flow and restore normal hemodynamics.
How common are deployment failures in thoracic stent grafts?
Device deployment failures are rare with modern endografts but carry catastrophic consequences when they occur. The mechanical failure identified in the Relay Pro represents a systematic defect in the unclasp mechanism, distinguishing it from random procedural complications. Bolton Medical’s voluntary recall indicates confidence that the issue is isolated to specific device lots rather than a design flaw affecting all units.
What alternative devices are available for patients who cannot receive a Relay Pro?
Multiple FDA-approved thoracic endografts are available, including systems from Medtronic, Gore, and Cook Medical. Your vascular surgeon will select the most appropriate alternative based on your aortic anatomy, disease pathology, and institutional experience. Rescheduling should not substantially delay your treatment unless emergency intervention is required.
This recall highlights the ongoing importance of post-market device surveillance and rapid communication between manufacturers, regulators, and clinical teams. Healthcare systems should use this alert as an opportunity to strengthen inventory management protocols and adverse event response procedures. Patients requiring thoracic aortic intervention should not delay care but should ensure their surgical team uses a device not affected by this recall.
Source: FDA Medical Device Recall Alert: Thoracic Stent Graft (Relay Pro System)
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