Artix MT Thrombectomy Device (Inari) – Vessel Range (2025)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artix MT Thrombectomy Device, REF: 32-102
Brand
Inari Medical Oak Canyon
Lot Codes / Batch Numbers
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Products Sold
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Inari Medical Oak Canyon is recalling Artix MT Thrombectomy Device, REF: 32-102 due to 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, . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 4/8/2025, correction and removal notices were distributed to customers who were asked to do the following: 1) Review notice and the accompanying copy of the device IFU (IU-01087 Rev. C) and disseminate it to any applicable personnel and device users at your facility and network to ensure they are aware of the unused device replacement. 2) Notice should be shared with any organization where affected devices may have been transferred. 3) Complete and return the acknowledgement reply form via email to If you have any questions, please contact your local sales representative, or the firm's Customer Service at 877-923-4747, or Quality department at QA@inarimedical.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026