FDA Medical Device Recalls (openFDA)
Inari Medical - Oak Canyon: Artix MT Thrombectomy Device, REF: 32-102
- Recall number
- Z-1728-2025
- Recalling firm
- Inari Medical - Oak Canyon
- Product
- Artix MT Thrombectomy Device, REF: 32-102
- Status
- Open, Classified
- Initiated
- 2025-04-08
- Posted
- 2025-05-06
- Terminated
- not on file
- 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 Customer Service at 877-923-4747, or Quality department at QA@inarimedical.com.
- Quantity
- 45
- Distribution
- US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
- Lot, serial or model codes
- UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
- 510(k) numbers
- K241894
- PMA numbers
- not on file
- Product code
- QEW
- Firm FEI
- 3020347218
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28