Boston Scientific recalled 150 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows increased reports of stent deployment and expansion issues, which could lead to serious medical interventions. Healthcare providers and patients must stop using the device immediately.
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 affected product is the *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 8mm x 8mm, with Material Number (UPN): M00553530. The recall includes lot numbers ranging from 35985705 to 36301620. The product was distributed worldwide, including across the United States and several countries in Europe, Asia, and Latin America.
Increased reports indicate issues with the deployment and expansion of the stent. The most serious foreseeable outcome includes complications requiring additional endoscopic or surgical intervention to remove the stent.
Patients and healthcare providers should immediately stop using the device. For further instructions, contact Boston Scientific Corporation or consult your healthcare provider.
For more information, contact Boston Scientific Corporation or visit their website. Additional details are available at the FDA's recall page.
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