Boston Scientific AXIOS Stent 8mm recalled for deployment and expansion issues
What this means
Boston Scientific is recalling certain AXIOS Stents (8mm x 8mm) used in medical procedures because they may not deploy or expand properly. If the stent fails to deploy correctly, additional procedures may be needed to remove it and repair the puncture site.
- If you recently had a procedure using an AXIOS Stent 8mm, contact your doctor immediately.
- Provide your doctor with the lot number from your procedure records if available.
- Ask your doctor whether your stent was affected and whether follow-up care is needed.
- Do not attempt to remove or adjust the stent yourself.
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-1160-2026More Boston Scientific recalls
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- 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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