FDA-Device2025-05-14Class II
Artix MT Thrombectomy Device, REF: 32-102
Inari Medical - Oak Canyon
Hazard
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.
Sold states
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Affected count
45
Manufactured in
6001 Oak Cyn, N/A, Irvine, CA, United States
Products
Artix MT Thrombectomy Device, REF: 32-102
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2025Don't want to check this manually?
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