Inari Medical - Oak Canyon: Device Recall

Recall #Z-1728-2025 · 04/08/2025

Class II: Risk

Recall Details

Recall Number: Z-1728-2025
Classification: Class II
Product Type: Device
Recalling Firm: Inari Medical - Oak Canyon
Status: Ongoing
Date Initiated: 04/08/2025
Location: Irvine, CA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 45

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.

Product Description

Artix MT Thrombectomy Device, REF: 32-102

Distribution Pattern

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

Other Recalls by Inari Medical - Oak Canyon

Class I: Dangerous 07/19/2024

Thrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent, calcified material, or suspected tumor thrombus overloading catheter bag 2) Catheter pulled through internal jugular vein access site or not pulled away from heart; may lead to device entrapment, pulmonary embolism, venous cutdown, abdominal surgery.

View all recalls by Inari Medical - Oak Canyon →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.