Artix MT Thrombectomy Device, REF: 32-102
Reported: May 14, 2025 Initiated: April 8, 2025 #Z-1728-2025
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.
Details
- Recalling Firm
- Inari Medical - Oak Canyon
- Units Affected
- 45
- Distribution
- US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Artix MT Thrombectomy Device, REF: 32-102. Recalled by Inari Medical - Oak Canyon. Units affected: 45.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Moderate. Recall number: Z-1728-2025.
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