Boston Scientific AXIOS Stent 6mm x 8mm recalled for deployment and expansion issues
What this means
Boston Scientific has recalled certain AXIOS Stents (6mm x 8mm) due to reports of problems with stent deployment and expansion during procedures. In some cases, the stent may not deploy properly, potentially requiring additional procedures to remove it and repair the site. No injuries have been reported.
- If you received an AXIOS Stent procedure with the affected lot numbers, contact your healthcare provider immediately
- Your doctor can verify whether your stent is affected and determine if monitoring or follow-up is needed
- Do not delay seeking care if you experience unusual symptoms following your procedure
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1159-2026More Boston Scientific recalls
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- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
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