Boston Scientific recalled 557 units of the AXIOS Stent and Electrocautery-Enhanced Delivery System on December 19, 2025. Increased reports of stent deployment and expansion issues prompted this recall. The defect may require additional medical intervention to resolve deployment failures.
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 recalled product is the AXIOS Stent and Electrocautery-Enhanced Delivery System, 20mm x 10mm, Material Number (UPN): M00553660. It was distributed worldwide, including the US and Puerto Rico, and had multiple lot numbers.
Reports indicate serious issues with stent deployment and expansion. Failure to deploy or expand the stent may necessitate additional endoscopic or surgical intervention.
The recall is classified as Class I, indicating a high risk of serious injury. Specific incident numbers were not disclosed.
Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation for further instructions.
For more information, visit https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1158-2026.
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