Recall Z-1728-2025 · QEW Peripheral Mechanical Thrombectomy With Aspiration
Inari Medical - Oak Canyon
Artix MT Thrombectomy Device, REF: 32-102
| Date | May 6, 2025 (initiated Apr 8, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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 |
| Quantity | 45 |
| Distribution | US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath Inari Medical, Inc., Oct 15, 2024 |