The U.S. Food and Drug Administration has issued a medical device early alert for certain lots of AXIOS Stent and Electrocautery-Enhanced Delivery System manufactured by Boston Scientific, following reports of deployment failures that may result in serious injury, procedural complications, or death.
The affected devices are used in therapeutic endoscopy for transgastric or transduodenal drainage of pancreatic fluid collections (including pseudocysts and walled-off necrosis) and, in select high-risk patients, for gallbladder drainage in acute cholecystitis.
According to the FDA, the issue occurs during stent delivery and deployment, when the device may fail to expand or deploy as intended. Successfully implanted stents are not affected. Deployment failures can prolong procedures, require device exchanges, and in some cases necessitate additional endoscopic or surgical intervention to manage the puncture site. As of late December 2025, 167 serious injuries and three deaths have been reported in association with the issue.