Inari Artix MT Thrombectomy Device Recalled for Incorrect Vessel Size Labeling

Agency Publication Date: May 6, 2025

Summary

Inari Medical - Oak Canyon is recalling 45 units of the Artix MT Thrombectomy Device (REF: 32-102) due to a labeling error on the packaging and instructions. The labels incorrectly state the device is safe for blood vessels as small as 2.5 mm, when the correct minimum vessel size is 3 mm. No incidents or injuries have been reported at this time.

Risk

Using the device in blood vessels smaller than the intended range can increase the radial force applied to the artery walls. This added pressure carries the potential for vascular complications or injury during the medical procedure.

What You Should Do

This recall affects the Artix MT Thrombectomy Device (REF: 32-102) with lot number 24100082 and an expiration date of 14 April 2025.
Identify affected products by checking the lot number and REF number printed on the device pouch, outer carton, and the Instructions for Use (IFU: IU-01087 Rev. B).
Stop using the recalled devices immediately and quarantine them to prevent further use in clinical procedures.
Contact Inari Medical - Oak Canyon or your distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or questions regarding medical device recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Artix MT Thrombectomy Device

Model / REF:

32-102

Lot Numbers:

24100082 (Exp 14 April 2025)

UDI:

00810123710584

Affected Instructions for Use (IFU): IU-01087 Rev. B

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96682

Status: Active

Manufacturer: Inari Medical - Oak Canyon

Sold By: Medical facilities; Hospitals

Manufactured In: United States

Units Affected: 45

Distributed To: Florida, Illinois, Wisconsin, Kentucky, Texas, California, Ohio, Georgia, Alaska, Michigan, Pennsylvania, Washington, Colorado

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects the Artix MT Thrombectomy Device (REF: 32-102) with lot number 24100082 and an expiration date of 14 April 2025.

Identify affected products by checking the lot number and REF number printed on the device pouch, outer carton, and the Instructions for Use (IFU: IU-01087 Rev. B).

Stop using the recalled devices immediately and quarantine them to prevent further use in clinical procedures.

Contact Inari Medical - Oak Canyon or your distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional assistance or questions regarding medical device recalls.