Z-1728-2025Class II

Artix MT Thrombectomy Device, REF: 32-102

Name: Z-1728-2025 Artix MT Thrombectomy Device, REF: 32-102
Creator: Inari Medical - Oak Canyon
Published: 2025-04-08
License: https://open.fda.gov/license/

Inari Medical, Inc. / initiated 2025-04-08 / Open, Classified / root cause: labeling and UDI

FDA source

Inari Medical - Oak Canyon began a recall of Artix MT Thrombectomy Device, REF: 32-102 on 2025-04-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1728-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-08
Posted: 2025-05-06
Recalling firm: Inari Medical, Inc.
Product: Artix MT Thrombectomy Device, REF: 32-102
Product code: QEW Peripheral Mechanical Thrombectomy With Aspiration
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.
Root cause tag: labeling and UDI
FDA 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 [email protected].
Quantity in commerce: 45
Distribution: US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Product codes and lots: UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1728-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1728-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-06

Product code QEW

K241894Class IIArtix™ MT; Artix™ Thin-Walled Thrombectomy SheathInari Medical, Inc. / cleared 2024-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)