Boston Scientific Corporation recalls HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.

• FDA enforcement recordOfficial FDA database entry for Z-1034-2025
• FDA 510(k) clearance · K233318The device's official FDA premarket clearance record
• FDA device classification · KNSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4300The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.