What question did this study set out to answer?

To provide interim recommendations regarding the use of lumen-apposing metal stents following the AXIOS device recall.

March 13, 2026Open Access

British Society of Gastroenterology interim technical review and position on the use of lumen opposing metal stents during therapeutic endoscopic ultrasound following the urgent medical device recall of the AXIOS stent and electrocautery enhanced delivery system

MHMatthew T HuggettSt James's University Hospital MNManu NayarNewcastle upon Tyne Hospitals NHS Foundation Trust JLJS LeedsNewcastle upon Tyne Hospitals NHS Foundation Trust

Key Points

To provide interim recommendations regarding the use of lumen-apposing metal stents following the AXIOS device recall.
Expert working group convened by the British Society of Gastroenterology (BSG).
Reviewed evidence for upcoming BSG T-EUS guidelines.
Developed consensus-based recommendations addressing alternative devices and strategies.
Viable options for PFC drainage and EUS-GBD include unaffected AXIOS sizes and alternative LAMS.
Malignant distal biliary obstruction requires consideration of larger LAMS and alternative stenting strategies.
Recommendations for recognizing and rescuing LAMS maldeployment provided, along with governance improvements.

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.

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