Boston Scientific Halts Use of Select Stent Delivery Devices After Patient Deaths

The company has removed certain AXIOS stents from clinical settings due to deployment issues linked to 167 injuries and 3 deaths.

Feb. 26, 2026 at 7:28pm

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Boston Scientific has initiated the removal of certain AXIOS Stents and Electrocautery-Enhanced Delivery Systems from clinical settings following reports of deployment complications that have been linked to serious injuries and deaths. The company notified affected customers in December 2025 to stop using and distributing the specific devices and remove remaining inventory from circulation.

Why it matters

The AXIOS Stent and Delivery System is used to enable endoscopic drainage of pancreatic pseudocysts or walled-off necrosis, as well as to assist gallbladder drainage in high-risk surgical patients. The recall highlights ongoing safety concerns with medical devices and the need for rigorous testing and monitoring to protect patient health.

The details

According to the FDA, the removal stems from increased reports of complications involving stent deployment and expansion at the time of placement. In some cases, difficulty deploying the device may prolong procedures and require replacement with a new system. If the first flange fails to deploy or expand, additional endoscopic or surgical intervention may be required to retrieve the device and close the puncture site. As of December 23, Boston Scientific reported 167 serious injuries and three deaths associated with the issue.

  • On December 19, 2025, Boston Scientific notified affected customers to stop using and distributing the specific devices.
  • As of December 23, 2025, Boston Scientific reported 167 serious injuries and three deaths associated with the deployment issues.

The players

Boston Scientific Corp

A medical device company that manufactures the AXIOS Stents and Electrocautery-Enhanced Delivery Systems.

U.S. Food and Drug Administration (FDA)

The federal agency that regulates medical devices and noted Boston Scientific's actions to remove the impacted systems from circulation.

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What’s next

The FDA and Boston Scientific will continue to monitor the situation and provide updates on any further actions or investigations.

The takeaway

This recall highlights the importance of rigorous safety testing and ongoing monitoring of medical devices to protect patient health. It also underscores the need for transparency and swift action by manufacturers and regulators when serious issues arise.