As of January 22, 2026, the FDA has issued an early alert regarding a potentially high-risk device issue with Boston Scientific’s Stent and Electrocautery-Enhanced Delivery System. This alert is crucial for healthcare professionals, particularly those involved in endoscopic procedures, as it may impact patient care and safety.
What Changed?
Boston Scientific has issued a letter to affected customers recommending that certain stents and electrocautery-enhanced delivery systems be removed from use or sale. The issue at hand involves increased reports of problems with stent deployment and expansion, which can occur during the delivery of the stent.
Affected Devices
The affected devices include the AXIOS Stent and Electrocautery-Enhanced Delivery System, which are used for transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts and/or walled-off necrosis. Certain models may also be used for drainage of the gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery.
Device Use and Safety
The AXIOS Stent and Electrocautery-Enhanced Delivery System are designed to facilitate endoscopic drainage procedures. However, the reported issues with stent deployment and expansion may lead to prolonged procedures, and in some cases, additional endoscopic or surgical intervention may be necessary to remove the stent and close the puncture site.
Actions Required
Healthcare professionals and facilities are advised to immediately stop using the affected devices and remove them from their inventory. They should also post this information in a visible location and share it with relevant personnel and organizations. Boston Scientific has reported 167 serious injuries and three deaths associated with this issue as of December 23.
Reporting Problems
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Boston Scientific at ComplaintCallCenter@bsci.com. Healthcare professionals and consumers can also report adverse reactions or quality problems to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Conclusion
In conclusion, the FDA’s early alert regarding Boston Scientific’s Stent and Electrocautery-Enhanced Delivery System is a critical notification for healthcare professionals and facilities. It is essential to take immediate action to ensure patient safety and prevent potential harm.
Disclaimer
This information is not intended to be legal advice. Healthcare professionals should consult the FDA’s website and relevant guidelines for the most up-to-date information on this issue.
FDA Link
For full information about the FDA announcement, see the link below.
https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-stent-and-electrocautery-enhanced-delivery-system-issue-boston-scientific