FDA Flags Boston Scientific Device Tied to 3 Deaths, Scores of Injuries

 The FDA sent an early safety alert warning clinicians of deployment failures with certain Boston Scientific AXIOS Stent and Electrocautery Enhanced Delivery Systems that have been linked to three deaths and 167 serious injuries.

The minimally invasive device is cleared for managing two serious complications of pancreatitis -- symptomatic pancreatic pseudocysts and walled-off pancreatic necrosis -- via endoscopic drainage. "Certain models may also be used to facilitate drainage of the gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery," the agency said.

Boston Scientific sent letters to customers last month notifying them of the urgent medical device recall, citing increased reports of problems with stent deployment and expansion at the time of delivery in certain AXIOS systems.

Difficulty deploying the stent may prolong the procedure and require the device to be exchanged, the FDA said. In cases where the first flange is unable to deploy or expand, additional endoscopic or surgical intervention may be needed to remove the stent and close the puncture site.

The issue does not affect stents that have been successfully implanted. Because the problem occurs only at the time of delivery, patients who already have an AXIOS stent in place should continue to receive standard follow-up care.

The counts of injuries and deaths were current as of Dec. 23, 2025, Boston Scientific said.

According to the company, the three deaths occurred in cases where the system was used outside of its indication or in an investigational manner "and required a cascade of events with special circumstances such as decision for palliative care, altered anatomy, or acute unrelated procedural complication, all of which limited further treatment options."

It's recommended that customers stop using and distributing the affected devices and remove them from inventory. Products should be segregated in a secure location until they can be returned, Boston Scientific said.

The company also reminded healthcare professionals that AXIOS stents should be used only as indicated in the instructions for use.

The FDA said it is continuing to review the issue and will provide updates as more information becomes available.

https://www.medpagetoday.com/publichealthpolicy/productalert/119484