*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | December 19, 2025 |
| Reported | February 11, 2026 |
| Recalling firm | Boston Scientific Corporation |
| Country / region | United States MA |
Hazard
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.
Affected products
- *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
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