| Developers: | Boston Scientific |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
2026: Finding a Marriage That Could Harm Health
On January 16, 2026, the US Food and Drug Administration (FDA) announced the recall of Boston Scientific Axios stents and their delivery systems due to an identified defect. The use of these products can cause significant harm to the health of patients and even provoke death.
The Axios stent system is designed for endoscopic transluminal drainage of symptomatic pancreatic pseudocysts. The procedure is performed under ultrasonic control. In addition, stents may be used to facilitate gallbladder drainage in patients with acute cholecystitis who are at high risk or who are contraindicated in surgery.
The main feature of Axios products is a unique shape in the form of a dumbbell: at the edges, the stent has zones with a larger diameter than in the central part, so it is securely held in the right place. Boston Scientific acquired the technology in a deal to buy Xlumena in 2015 for $62.5 million.
The FDA notice says there may be problems installing and expanding them when using defective Axios stents. This leads to an increase in the time of the procedure and increases the likelihood of failure. In particular, in some cases, additional endoscopic or surgical intervention may be required to remove the stent. As of December 23, 2025, Boston Scientific reported 167 serious injuries and three deaths related to the defect. In this regard, all medical institutions and other organizations that purchased this product are advised to stop using and/or distributing it.[1]
Notes
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