Artix MT recallZ-1728-2025 · Inari Medical - Oak Canyon · initiated Apr 8, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Inari Medical - Oak Canyon or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Labeling Change Control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1728-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 8, 2025
- Posted by the FDA
- May 6, 2025
- Recalling firm
- Inari Medical - Oak Canyon
- Quantity
- 45
- Product code
- QEW
- FDA submissions
- K241894
- Distribution
- US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Product description
Artix MT Thrombectomy Device, REF: 32-102
Code information (models, lots, serial numbers)
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Artix MT 32-102 / AS-01248Inari Medical, Inc. · Catheter, Continuous Flush1 recall4 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K241894 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Artix Thin-Walled Sheath 30-103 / AS-01216Inari Medical, Inc. · Catheter, Continuous Flush13 reports
- Artix Thin-Walled Sheath 30-104 / AS-01206Inari Medical, Inc. · Catheter, Continuous Flush4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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