FDA Enforcement
Class II
Ongoing
Artix MT Thrombectomy Device, REF: 32-102
Recall: Z-1728-2025
·
Reported May 14, 2025
Enforcement
- Recall Number
- Z-1728-2025
- Event ID
- 96682
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Inari Medical - Oak Canyon
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 14, 2025
- Initiation Date
- April 8, 2025
- Classification Date
- May 6, 2025
- Address
- 6001 Oak Cyn, N/A, Irvine, CA, 92618-5200, United States
Description
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.
Code Info
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Distribution
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Quantity
45