Boston Scientific Issues Stop-Use Notice for Axios Stents After Fatalities

Boston Scientific has advised customers to stop using certain Axios Stents and Electrocautery Enhanced Delivery Systems following three deaths linked to off-label or investigational use, the FDA reported. The alert cites 167 serious injuries associated with deployment and expansion issues.

Axios stents are used for transgastric or transduodenal drainage of pancreatic pseudocysts or walled-off necrosis, and for gallbladder drainage in high-risk patients. Deployment problems can prolong procedures, sometimes requiring additional endoscopic or surgical intervention if the stent fails to expand properly. Successfully implanted stents are not affected.

The three deaths occurred during unapproved EDGE procedures, gastrojejunostomy, and an investigational gastroenterostomy trial, often under complex clinical circumstances.

Axios is a key Boston Scientific product, enabling procedures previously done surgically to be performed endoscopically. This FDA alert follows a Class 2 recall of Axios devices last year for similar expansion issues.

20-01-2026