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Inari Medical - Oak Canyon recalls Artix MT Thrombectomy Device, REF: 32-102
Recalled May 14, 2025 · FDA recall Z-1728-2025 · 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. · FDA Class II
Units
45
Sold at
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Description
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.
Product
Artix MT Thrombectomy Device, REF: 32-102
Manufacturer(s)
Inari Medical - Oak Canyon
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →