Boston Scientific HOT AXIOS Stent recalled for deployment and expansion issues
What this means
Boston Scientific's HOT AXIOS Stent (6mm × 8mm) may fail to deploy or expand properly during placement. If the stent does not expand correctly, patients may need additional endoscopic or surgical procedures to remove it and repair the puncture site.
- Contact your healthcare provider if you received this device
- Check the lot number on your device documentation against the FDA recall list
- Do not use affected units; return them to Boston Scientific or your distributor
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-1161-2026More 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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