Inari Medical - Oak Canyon recalls Artix MT Thrombectomy Device, REF: 32-102

Recall date

April 8, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1728-2025

FDA classification

Class II

Brand / firm

Inari Medical - Oak Canyon

Sold / distributed

US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Artix MT Thrombectomy Device, REF: 32-102