# FDA recall Z-1728-2025

> **Inari Medical - Oak Canyon** · Class II · device recall initiated 2025-04-08.

## 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

- **Recall number:** Z-1728-2025
- **Recalling firm:** Inari Medical - Oak Canyon
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-08
- **Report date:** 2025-05-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1728-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-1728-2025. Source: US FDA. Licensed CC0.

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