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 is used in various endoscopic procedures to maintain the patency of lumens or ducts. It is intended for patients requiring stent placement due to various medical conditions.
Issues with deploying the AXIOS Stent can lead to complications such as prolonged procedures and the need for further surgical intervention. This creates significant risks for patients during treatment.
This recall is not part of a broader industry pattern.
Affected patients may face delays in treatment or additional medical procedures, which could lead to increased healthcare costs and extended recovery times.
The material number and lot numbers are typically printed on the packaging and the stent label.
Expect a refund or replacement processing timeline of approximately 4-6 weeks after following the return instructions.
Keep records of your stent's material number, lot number, and any correspondence regarding the recall.
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.
Not sure what to do next? Our guide walks you through the process step by step.
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