Inari Medical - Oak Canyon recalls Artix MT Thrombectomy Device

Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.

On 4/8/2025, correction and removal notices were distributed to customers who were asked to do the following: 1) Review notice and the accompanying copy of the device IFU (IU-01087 Rev. C) and disseminate it to any applicable personnel and device users at your facility and network to ensure they are aware of the unused device replacement. 2) Notice should be shared with any organization where affected devices may have been transferred. 3) Complete and return the acknowledgement reply form via email to If you have any questions, please contact your local sales representative, or the firm's Customer Service at 877-923-4747, or Quality department at QA@inarimedical.com.

• FDA enforcement recordOfficial FDA database entry for Z-1728-2025
• FDA 510(k) clearance · K241894The device's official FDA premarket clearance record
• FDA device classification · QEWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.5150The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Inari Medical - Oak CanyonSearch 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.