Summary
The FDA issued a Class II for Artix MT Thrombectomy Device, REF: 32-102 by Inari Medical - Oak Canyon. 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, .
Details
Source
Device Recall
External ID
Z-1728-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
Artix MT Thrombectomy Device, REF: 32-102
Lot/Code Info: UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Quantity Affected: 45
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.
Distribution
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-08
Company
Irvine, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Inari Medical - Oak Canyon has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inari Medical - Oak Canyon) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inari Medical - Oak Canyon have FDA actions?
Inari Medical - Oak Canyon has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1728-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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