Boston Scientific Advises Removal Of Certain AXIOS Stents After Deployment Issues Surface

The U.S. Food and Drug Administration (FDA) said it is aware that Boston Scientific Corporation (NYSE:BSX) has alerted customers to remove certain AXIOS stents and electrocautery-enhanced delivery systems from use and distribution, citing concerns that could pose a high risk to patients during procedures.

According to the FDA website, Boston Scientific sent a letter on Dec. 19, 2025, to all affected customers recommending the immediate halt of use and distribution of any remaining impacted devices.

Boston Scientific reported that certain AXIOS Stent and Electrocautery-Enhanced Delivery Systems have shown increased reports of difficulty with stent deployment and expansion.

These complications arise at the time of delivery and do not affect stents that have already been successfully implanted.

In some cases, difficulty deploying the stent may extend procedure times and require the device to ...