Recall Z-1728-2025— Inari Medical - Oak Canyon

Name: FDA recall Z-1728-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-08

Class II · Ongoing

Class II FDA medical device recall by Inari Medical - Oak Canyon, initiated 2025-04-08. It names one FDA 510(k) clearance: K241894. Product: Artix MT Thrombectomy Device, REF: 32-102. Reason: 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..

Recalling firm: Inari Medical - Oak Canyon
Classification: Class II
Status: Ongoing
Initiated: 2025-04-08
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K241894 — Artix MT; Artix Thin-Walled Thrombectomy SheathInari Medical, Inc.·cleared 2024-10-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.