On December 19, 2025, Boston Scientific instructed healthcare providers and distributors to stop using and distributing certain AXIOS Electrocautery-Enhanced Stents and Delivery Systems, isolating remaining inventory for return. Affected units were identified by model and lot number, with immediate actions required to prevent further use in clinical procedures.

By December 23, the company had logged 167 serious injuries and three patient deaths attributed to complications during stent deployment, including failure of the first flange to expand. In several cases, clinicians needed additional endoscopic or surgical intervention to retrieve devices and close puncture sites, extending procedure times and raising safety concerns.

The recall and removal of these devices are expected to reduce procedure volumes for endoscopic drainage and gallbladder interventions in the near term. Boston Scientific may face remediation costs, potential legal liabilities, and a temporary decline in device revenue as it addresses customer concerns and complies with regulatory follow-up requirements.