Boston Scientific Recalls HOT AXIOS Stent and Delivery System Due to Deployment Failures

What Happened

Boston Scientific Corporation has initiated a voluntary recall of the HOT 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 firm, these malfunctions can lead to procedural complications that may necessitate additional medical interventions.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: HOT AXIOS Stent and Electrocautery-Enhanced Delivery System (20mm x 10mm)
• Material Number (UPN): M00553560
• UDI-DI: 8714729951100
• Recall Number: Z-1163-2026
• Quantity: 588 units
• Affected Lot Numbers: This recall includes over 200 specific lot numbers, including but not limited to: 35793920, 35952745, 35961004, 35995006, 35995007, 35995165, 36001950, 36001951, 36001952, 36001953, 36002902, and 36002903.

This product was distributed worldwide, including nationwide across the United States and Puerto Rico, as well as in over 50 other countries including Canada, Germany, Japan, and the United Kingdom.

What You Should Do

Healthcare facilities and providers should immediately identify and sequester any affected units in their inventory. Boston Scientific Corporation, located at 100 Boston Scientific Way, Marlborough, MA 01752, initiated this voluntary recall on December 19, 2025. Providers should follow the firm’s instructions for the return or exchange of the affected devices.

Why This Matters

Difficulty in deploying or expanding the stent can lead to a prolongation of the medical procedure. In the most serious cases, a failure of the first flange to deploy or expand can result in a cascade of events requiring additional endoscopic or surgical intervention to remove the stent and close the puncture site.

Source

Information provided by the FDA.