Class II
Medical Device Recall: Artix MT Thrombectomy Device, REF: 32-102
Inari Medical - Oak Canyon · April 8, 2025
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
States Affected
NATIONWIDE
Quantity Affected
45
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1728-2025
Status: ongoing
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