Boston Scientific recalled 39 AXIOS Stent and Electrocautery-Enhanced Delivery Systems on December 19, 2025. Reports indicated issues with stent deployment and expansion, potentially leading to additional surgical interventions. The recall affects units distributed worldwide, including the United States and several other countries.
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 a medical device used to facilitate procedures involving stent placement in various medical treatments. Healthcare providers typically use it during endoscopic interventions.
The defect in deployment and expansion of the stent can lead to procedural complications, potentially requiring additional medical interventions, which may be invasive.
This recall is not part of a broader industry pattern.
The recall may cause inconvenience for patients who need immediate stent placement, as it could delay necessary medical procedures.
You can find the Material Number on the product packaging or accompanying documentation provided by the manufacturer.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep records of all communications, receipts, and any relevant documentation regarding the recalled product.
The recalled product is the AXIOS Stent and Electrocautery-Enhanced Delivery System, Material Number M00553680. The recall includes 39 units distributed globally, including the U.S. and Puerto Rico, as well as various countries in Europe, Asia, and South America.
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