Boston Scientific Recalls AXIOS Stent and Delivery System Due to Deployment Risks

What Happened

Boston Scientific Corporation has initiated a voluntary Class I recall of the AXIOS Stent and Electrocautery-Enhanced Delivery System. The recall was triggered by an increase in reports regarding stent deployment and expansion issues. According to the manufacturer, these malfunctions can lead to procedural complications, including the inability to properly deploy the device’s first flange.

Which Products Are Affected

The recall affects 557 units distributed worldwide, including throughout the United States and Puerto Rico. Affected products include:

• Product Name: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm
• Material Number (UPN): M00553660 / M00553680
• UDI-DI: 8714729951179
• Recall Number: Z-1158-2026
• Lot Numbers: Over 200 specific lots are affected, including (but not limited to) 35961006, 35961007, 35962524, 35967379, 35968520, 36109761, 36217768, 36325560, 36478478, 36603384, 37050321, 37459573, and 37844023.

What You Should Do

This is a firm-initiated voluntary recall. Healthcare facilities and providers in possession of the affected lots should follow the instructions provided by Boston Scientific Corporation. The firm initiated the notification process on December 19, 2025. Facilities should identify any remaining inventory of the specified material and lot numbers to prevent further use during medical procedures.

Why This Matters

Difficulty deploying or expanding the stent typically results in prolonged medical procedures to exchange the device. In the most serious cases, a failure of the first flange to deploy can necessitate additional endoscopic or surgical intervention to remove the stent and close the puncture site, posing a significant health risk to the patient.

Source

FDA Recall Notification