Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
Bolton Medical is removing the Relay Pro Thoracic Stent Graft System because the grafts may fail to unclasp from the delivery system during deployment. This technical failure can necessitate emergency conversion to open surgical repair and carries a risk of patient mortality.
Bolton Medical, cardiovascular surgical departments, and regulatory/QA professionals overseeing thoracic endovascular aortic repair (TEVAR) device portfolios.
The severity of the reported failure—potential inability to release the implant—represents a critical mechanical malfunction that directly jeopardizes patient safety by forcing invasive rescue surgeries. This indicates a high-risk failure mode within the delivery system's design or manufacturing process, likely triggering intensive CAPA investigations and rigorous scrutiny of the product's 510(k) or PMA technical file by regulators.
Regulatory and QA teams should immediately verify inventory for the Relay Pro System, execute quarantine procedures, and coordinate with clinical sites to ensure surgeons are aware of the risk of delivery system failure. Post-market teams should review existing adverse event reports for similar deployment malfunctions.
Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.
Open in openFDA / FDA.gov