Boston Scientific Corporation has discontinued distribution of select AXIOS Stent and Electrocautery-Enhanced Delivery Systems following reports of deployment failures that have resulted in serious patient injuries and fatalities. The medical device manufacturer reported 167 serious adverse events and three deaths associated with the devices as of December 23, 2025. The incidents have been linked to complications during device deployment that created unexpected patient safety risks.
The U.S. Food and Drug Administration issued guidance on December 19, 2025, directing healthcare facilities to cease using the affected delivery systems and remove remaining inventory from clinical use. Boston Scientific subsequently implemented a halt on the distribution of the implicated devices to ensure patient safety across its customer base. The company's action reflects standard industry protocols when deployment complications pose risks to patient outcomes.
Boston Scientific stated it is cooperating with the FDA and conducting a comprehensive investigation into the root causes of the deployment failures. The company has not disclosed specific details regarding the particular AXIOS models affected or the timeline for potential resolution. Healthcare providers utilizing these devices have been advised to consult with Boston Scientific and the FDA for guidance on alternative treatment options and proper device handling procedures.