Boston Scientific AXIOS Stent recalled for deployment and expansion issues
What this means
Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) due to reports of deployment and expansion problems during use. If a stent fails to deploy properly, patients may need additional procedures to remove it and repair the puncture site.
- If you received an AXIOS Stent, contact your doctor or hospital immediately with your lot number
- Do not assume your stent is affected—your healthcare provider can confirm if yours is part of the recall
- Keep your stent packaging or medical records handy to provide the lot number to your doctor
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-1162-2026More Boston Scientific recalls
- FDA-Device2026-09-09Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- 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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