FDA Devices recall · Reported February 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the pro…
Boston Scientific Corporation recalled AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UP… - a critical-severity action.
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UP… was recalled by Boston Scientific Corporation in February 11, 2026. Reason: Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable re…. Check the official notice for the remedy. Verify recall #Z-1159-2026 with the FDA Devices before acting.
The recall
Boston Scientific Corporation issued this critical-severity FDA Devices recall-Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable re….
- Critical
- severity level
- 39 units
- affected scope
- Class I
- classification
- February 11, 2026
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1159-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1159-2026 |
| Date reported | February 11, 2026 |
| Date initiated | December 19, 2025 |
| Recalling firm | Boston Scientific Corporation |
| Firm location | Marlborough, MA |
| Affected scope | 39 units |
| Distribution | Worldwide distribution. US Nationwide including Puerto Rico; Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia,… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1159-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Critical), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026