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 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.
Reports indicate increased difficulties with stent deployment and expansion. The most serious outcome could involve additional interventions, either endoscopic or surgical, to remove the stent and close the puncture site.
The recall is classified as Class I, indicating a high risk of injury. While specific incident counts were not disclosed, the potential for serious complications necessitates immediate action.
Patients and healthcare providers should cease use of the device immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1163-2026.
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