Abstract

Background
On 20 December 2025, Boston Scientific initiated an urgent field safety notice and recall of selected Hot AXIOS lumen-apposing metal stent (LAMS) systems (6×8 mm, 8×8 mm and 20×10 mm) following reports of deployment and expansion failures at the time of delivery. These devices are widely used in the UK for therapeutic endoscopic ultrasound (T-EUS), including pancreatic fluid collection (PFC) drainage, EUS-guided gallbladder drainage (EUS-GBD), choledochoduodenostomy (EUS-CDD), gastrojejunostomy (EUS-GJ) and EUS-Directed transgastric endoscopic retrograde cholangio pancreatography (ERCP) (EDGE) procedures. The recall has immediate implications for urgent and complex interventions.

Methods
The British Society of Gastroenterology (BSG) Endoscopy Committee convened an expert working group comprising members of the committee and UK T-EUS leaders. Using evidence synthesised for the forthcoming BSG T-EUS Guidelines, the group developed consensus-based interim recommendations addressing alternative devices, technical strategies, salvage of stent maldeployment and governance measures. All recommendations achieved 100% agreement and were ratified by the BSG Endoscopy Committee.

Results
For PFC drainage and EUS-GBD, unaffected AXIOS sizes and alternative LAMS (eg, HOT SPAXUS, Z-EUS) remain viable options, with plastic stents or percutaneous approaches as adjuncts. The greatest impact is in malignant distal biliary obstruction, where withdrawal of 6×8 mm and 8×8 mm devices necessitates consideration of 10×10 mm LAMS in selected cases, alternative LAMS, tubular self-expanding metal stents, EUS-rendezvous, EUS-guided hepaticogastrostomy or antegrade stenting. For EUS-GJ and EDGE, the use of smaller LAMS or staged techniques is advised. Practical guidance for recognition and rescue of LAMS maldeployment is summarised, alongside recommendations for enhanced governance, regional collaboration and prospective data capture.

Conclusion
This interim BSG position statement provides pragmatic, consensus-driven guidance to maintain safe and effective T-EUS practice in the UK following the AXIOS recall. These recommendations support clinical decision-making during this period of device limitation and complement forthcoming national guidelines.