Boston Scientific recalled 266 units of the HOT AXIOS Stent on December 19, 2025. Reports indicated deployment and expansion problems, posing risks of prolonged procedures and additional surgical interventions. Consumers must stop using the device immediately and follow the manufacturer's 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 HOT AXIOS Stent is designed for use in endoscopic procedures to facilitate drainage. It is often used in patients requiring biliary or gastrointestinal interventions.
Deployment issues can lead to complications, including the inability to properly position the stent, which may necessitate additional surgical procedures.
This recall is not part of a broader industry pattern.
The recall impacts healthcare procedures, potentially leading to delays and increased patient risk during stent placement.
Lot numbers and material numbers can typically be found on the packaging or product documentation.
Refund processing may take approximately 4-6 weeks after the manufacturer receives the returned product.
Keep records of your purchase, correspondence with the manufacturer, and any medical documentation related to your use of the stent.
The recalled product is the HOT AXIOS Stent and Electrocautery-Enhanced Delivery System, 6mm x 8mm, Material Number M00553520. It was distributed worldwide, including the U.S. and Puerto Rico. Specific lot numbers affected include 36067957 through 36154529.
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