The recall involves problems with stent deployment and expansion, according to the notice that the FDA published on Jan. 16. Regulatory reports in countries including the U.K. and Malaysia say the issues were associated with investigational (off-label) uses and required a cascade of events with special circumstances.
According to the FDA, Boston Scientific had reported 167 serious injuries and three deaths associated with this issue as of Dec. 23, 2025.
The Axios stent system is designed for endoscopic ultrasound-guided transluminal drainage of symptomatic pancreatic pseudocysts. Boston Scientific acquired the technology through its $62.5 million buyout of Xlumena in 2015, followed by the launch of the Axios system in 2016.
During Boston Scientific’s third-quarter earnings call in October, CEO Mike Mahoney credited double-digit growth in key products, including Axios, Mantis, and Overstitch, for driving 9% growth in the Endoscopy business.
Boston Scientific sent a Dec. 19 letter to affected health provider customers, recommending that they immediately stop further distribution or use of any remaining affected devices, remove them from their inventory, and keep them in a secure location until they can be returned to the company.
The FDA notice includes a list of unique device identifier numbers and UPNs for the affected Axios systems.
