Boston Scientific recalled 588 units of its *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. The recall follows multiple reports of stent deployment and expansion issues, posing serious risks during medical procedures.
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 *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System is designed for use in endoscopic procedures. It helps facilitate the placement of stents for various medical conditions.
Deployment difficulties may prevent the stent from functioning as intended, potentially leading to extended medical procedures or the need for surgical intervention.
This recall is not part of a broader industry pattern.
The recall may lead to increased procedure times and the risk of complications for patients, necessitating immediate cessation of use.
The material number and lot numbers can be found on the product packaging or accompanying documentation.
Expect a refund or replacement processing timeline of approximately 4-6 weeks.
Keep copies of any correspondence with the manufacturer and retain any receipts or documentation related to the stent.
The recall involves the *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, Material Number (UPN): M00553560. It was distributed worldwide, including the US and several other countries. The stent dimensions are 20mm x 10mm.
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