The U.S. Food and Drug Administration (FDA) said it is aware that Boston Scientific Corporation (NYSE:BSX) has alerted customers to remove certain AXIOS stents and electrocautery-enhanced delivery systems from use and distribution, citing concerns that could pose a high risk to patients during procedures.
According to the FDA website, Boston Scientific sent a letter on Dec. 19, 2025, to all affected customers recommending the immediate halt of use and distribution of any remaining impacted devices.
Boston Scientific reported that certain AXIOS Stent and Electrocautery-Enhanced Delivery Systems have shown increased reports of difficulty with stent deployment and expansion.
These complications arise at the time of delivery and do not affect stents that have already been successfully implanted.
In some cases, difficulty deploying the stent may extend procedure times and require the device to be replaced. If the first flange fails to deploy or expand, additional endoscopic or surgical intervention may be necessary to remove the stent and close the puncture site.
As of December 23, Boston Scientific reported 167 serious injuries and three deaths associated with the issue.
The AXIOS Electrocautery-Enhanced Stent and Delivery System is used to enable endoscopic drainage of pancreatic pseudocysts or walled-off necrosis.
Certain models are also indicated for gallbladder drainage in high-risk patients with acute cholecystitis who are not suitable candidates for surgery.
The company instructed facilities to remove the products from inventory, segregate them in a secure location, and arrange for their return.
The agency emphasized that patients with successfully implanted AXIOS stents should continue standard follow-up care, as the reported issue occurs only during delivery, not after implantation.
Boston Scientific also advised healthcare providers to prominently post the notification near affected products to ensure visibility for all users and handlers.
Facilities were instructed to share the alert internally with healthcare professionals and externally with any organizations that may have received the devices.
Distributors were told to forward the notice to customers, while hospital systems were asked to notify other facilities within their networks that may hold the products.
The FDA said it is actively reviewing information related to what it described as a potentially high-risk device issue and will provide updates as significant new details become available.
Last Thursday, Boston Scientific agreed to acquire Penumbra, Inc. (NYSE:PEN) in a cash-and-stock deal, representing a roughly $14.5 billion enterprise value.
In December 2025, Medtronic Plc (NYSE:MDT) notified customers to remove certain Left Heart Vent Catheters from use and sale, citing safety concerns.
According to Medtronic, the affected catheters may fail to hold their shape when bent, despite being designed to remain malleable and retain shaft positioning.
Price Action: BSX stock is up 0.64% at $91.77 at the last check on Wednesday.
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