FDA recall Z-1728-2025

Inari Medical - Oak Canyon · Class II · device

Product

Artix MT Thrombectomy Device, REF: 32-102

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.

Key facts

Status
Ongoing
Initiation date
2025-04-08
Report date
2025-05-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1728-2025