Boston Scientific announced a Class I recall of its AXIOS Stent and Electrocautery‑Enhanced Delivery System on February 27, 2026, after the FDA classified the recall as the most serious category. The recall follows 167 reported injuries and three deaths linked to the device.
The recall was initiated by Boston Scientific on December 19, 2025, with a Field Safety Notice issued on December 29, 2025. The FDA updated its communication to classify the recall as Class I on February 25, 2026, and the company publicly announced the recall on February 27, 2026.
The recall is driven by deployment and expansion issues that occur during delivery of the stent. The problems do not affect stents that have already been successfully implanted, but failed deployments can require additional endoscopic or surgical intervention. The three deaths were associated with off‑label use of the device in procedures such as EDGE or investigational applications. A Class II recall of the same product was issued about a year earlier for similar expansion concerns.
Boston Scientific’s gastrointestinal product line, which includes the AXIOS stent, contributed significantly to the company’s 2025 results. Net sales for the full year were $5.286 billion, up 15.9% year‑over‑year, and adjusted earnings per share were $0.80. The recall could translate into sales losses, increased liability costs, and higher regulatory scrutiny for this segment, potentially affecting future quarterly performance.
The recall adds to regulatory scrutiny and may impact Boston Scientific’s reputation for product safety. The company’s strong financial position—evidenced by robust 2025 earnings—provides a buffer, but the recall underscores the importance of rigorous quality control and post‑market surveillance.
In light of the recall, Boston Scientific’s management has emphasized its commitment to patient safety and to working closely with the FDA to resolve the issues. The company has also highlighted its ongoing investments in product development and quality systems to prevent future incidents.
The recall represents a significant event for Boston Scientific, highlighting the critical balance between innovation and safety in medical device manufacturing. The company’s ability to manage the recall and maintain confidence among clinicians and patients will be closely watched by stakeholders moving forward.
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