Recall Z-1728-2025
Inari Medical - Oak Canyon · initiated April 8, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Artix MT Thrombectomy Device, REF: 32-102
Codes / lots: UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-1728-2025
- Initiated
- April 8, 2025
- Posted by FDA
- May 6, 2025
- Product code
- QEW – Peripheral Mechanical Thrombectomy With Aspiration
- Quantity
- 45
- Distribution
- US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
- Recalling firm
- Inari Medical - Oak Canyon, Irvine, CA