Boston Scientific Corp (NYSE:BSX) on Wednesday 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.
Stent Use
The AXIOS Electrocautery-Enhanced Stent and Delivery System is designed to enable endoscopic drainage of pancreatic pseudocysts or walled-off necrosis through transgastric or transduodenal access.
Certain models are also used to assist gallbladder drainage in high-risk surgical patients with acute cholecystitis, inflammation of the gallbladder.
Actions To Be Taken
According to the U.S. Food and Drug Administration (FDA), the company notified affected customers on December 19, 2025, advising them to stop using and distributing specific devices and to remove remaining inventory from circulation.
The agency noted that patients with successfully implanted AXIOS stents can continue standard follow-up care, as the issue occurs during delivery rather than after placement.
The company instructed healthcare providers and distributors to immediately halt further use of the impacted systems and isolate them for return.
Boston Scientific emphasized that AXIOS Stents should continue to be used only in accordance with their approved Instructions for Use.
Potential Risks
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.
BSX Price Action: Boston Scientific shares were up 2.57% at $75.37 at the time of publication on Thursday, according to Benzinga Pro data.
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