Boston Scientific Corporation, a leading medical device company traded on the New York Stock Exchange under the ticker BSX, has recently communicated a critical safety advisory to healthcare providers regarding specific AXIOS Stents and their Electrocautery-Enhanced Delivery Systems. The company has instructed all affected customers to immediately halt the use and distribution of these devices due to deployment issues that present significant risks during endoscopic procedures.
In a letter dated December 19, 2025, Boston Scientific alerted clients that certain models of the AXIOS Stent and Electrocautery-Enhanced Delivery Systems have experienced an increase in reported difficulties related to the deployment and expansion of the stents at the point of delivery. These issues do not affect devices that have already been implanted successfully. However, the complications encountered during deployment can result in prolonged procedure times and may necessitate the replacement of the device during the procedure.
The most concerning deployment challenge arises if the initial flange of the stent fails to deploy or expand properly. Such failures may require subsequent medical intervention, including additional endoscopic procedures or surgical measures, to extract the stent and securely close the puncture site created during the procedure. As of December 23, 2025, Boston Scientific has reported a total of 167 serious injuries and three fatalities associated with these device problems.
The AXIOS Electrocautery-Enhanced Stent and Delivery System is primarily intended for endoscopic drainage treatments of pancreatic pseudocysts or walled-off necrosis. Some models also serve as an alternative for gallbladder drainage in patients at high surgical risk who suffer from acute cholecystitis and cannot undergo traditional surgical procedures.
In response to these safety concerns, Boston Scientific has directed medical facilities to immediately remove the affected products from their inventories. The recalled devices must be segregated in a secure location and arrangements made for their prompt return to the company.
The FDA has acknowledged the recall notice and confirmed that it is monitoring the situation closely due to the potentially high-risk nature of the device malfunction. The agency reassures patients who already have the AXIOS stent successfully implanted that there is no new risk from the implanted device itself and recommends that they continue their usual follow-up care.
Boston Scientific has also mandated that facilities visibly post the recall notification near the affected medical products to increase awareness among all healthcare professionals who may handle these devices. They are instructed to share the alert internally within their organizations and externally with any affiliated or recipient healthcare entities that might have received the recalled devices.
Distributors have been directed to forward the recall information to their customers, and hospital networks must ensure that the notification reaches all their affiliated facilities that might possess any of the impacted products.
Meanwhile, the FDA continues its ongoing investigation of the deployment issue and has committed to providing updates when new and relevant information becomes available. This medical device recall coincides with Boston Scientific's recent agreement to acquire Penumbra, Inc., a transaction valued at roughly 14.5 billion dollars in enterprise value, combining cash and stock components.
Separately, Medtronic Plc, another major medical device manufacturer, issued a similar safety recommendation in December 2025, advising customers to remove certain Left Heart Vent Catheters from use and sales channels. Medtronic's concern centered on these catheters potentially losing their shape when bent, in contrast to the product's design intended to retain malleability and position stability.
In summary, the recall of the AXIOS stents highlights the critical need for vigilance in monitoring medical device performance in clinical settings and the importance of prompt action to protect patient safety once issues are identified.
In a letter dated December 19, 2025, Boston Scientific alerted clients that certain models of the AXIOS Stent and Electrocautery-Enhanced Delivery Systems have experienced an increase in reported difficulties related to the deployment and expansion of the stents at the point of delivery. These issues do not affect devices that have already been implanted successfully. However, the complications encountered during deployment can result in prolonged procedure times and may necessitate the replacement of the device during the procedure.
The most concerning deployment challenge arises if the initial flange of the stent fails to deploy or expand properly. Such failures may require subsequent medical intervention, including additional endoscopic procedures or surgical measures, to extract the stent and securely close the puncture site created during the procedure. As of December 23, 2025, Boston Scientific has reported a total of 167 serious injuries and three fatalities associated with these device problems.
The AXIOS Electrocautery-Enhanced Stent and Delivery System is primarily intended for endoscopic drainage treatments of pancreatic pseudocysts or walled-off necrosis. Some models also serve as an alternative for gallbladder drainage in patients at high surgical risk who suffer from acute cholecystitis and cannot undergo traditional surgical procedures.
In response to these safety concerns, Boston Scientific has directed medical facilities to immediately remove the affected products from their inventories. The recalled devices must be segregated in a secure location and arrangements made for their prompt return to the company.
The FDA has acknowledged the recall notice and confirmed that it is monitoring the situation closely due to the potentially high-risk nature of the device malfunction. The agency reassures patients who already have the AXIOS stent successfully implanted that there is no new risk from the implanted device itself and recommends that they continue their usual follow-up care.
Boston Scientific has also mandated that facilities visibly post the recall notification near the affected medical products to increase awareness among all healthcare professionals who may handle these devices. They are instructed to share the alert internally within their organizations and externally with any affiliated or recipient healthcare entities that might have received the recalled devices.
Distributors have been directed to forward the recall information to their customers, and hospital networks must ensure that the notification reaches all their affiliated facilities that might possess any of the impacted products.
Meanwhile, the FDA continues its ongoing investigation of the deployment issue and has committed to providing updates when new and relevant information becomes available. This medical device recall coincides with Boston Scientific's recent agreement to acquire Penumbra, Inc., a transaction valued at roughly 14.5 billion dollars in enterprise value, combining cash and stock components.
Separately, Medtronic Plc, another major medical device manufacturer, issued a similar safety recommendation in December 2025, advising customers to remove certain Left Heart Vent Catheters from use and sales channels. Medtronic's concern centered on these catheters potentially losing their shape when bent, in contrast to the product's design intended to retain malleability and position stability.
In summary, the recall of the AXIOS stents highlights the critical need for vigilance in monitoring medical device performance in clinical settings and the importance of prompt action to protect patient safety once issues are identified.