Boston Scientific recalled 59 AXIOS Stents on December 19, 2025. Increased reports of deployment and expansion issues pose serious risks during procedures. Users should stop using the devices immediately and follow recall instructions.
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: N/A
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The AXIOS Stent and Electrocautery-Enhanced Delivery System measures 8mm x 8mm. It was distributed worldwide, including in the U.S. and Puerto Rico, from multiple retailers.
Reports indicate difficulties in deploying the stent, which can prolong procedures. In severe cases, failure to deploy the stent properly may require additional endoscopic or surgical intervention.
There are no specific injury or death counts reported at this time. The most serious outcomes involve additional medical intervention due to deployment issues.
Stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, call Boston Scientific Corporation or visit their website. Details are also available at the FDA recall page.
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