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 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.
The recall stems from increased reports of stent deployment and expansion issues. Difficulty deploying the stent can prolong procedures and lead to further interventions to remove the stent.
There have been no specific numbers of injuries reported, but the potential for serious complications exists, including the need for additional endoscopic or surgical procedures.
Patients and healthcare providers should stop using 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-1161-2026.
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