FDA Medical devices recall ·
Artix MT Thrombectomy Device recall
- Recall number
- Z-1728-2025
- Date
- (initiated April 8, 2025)
- Company / brand
- Inari Medical - Oak Canyon
6001 Oak Cyn, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 45
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Artix MT Thrombectomy Device, REF: 32-102
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Distribution
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
States: Alaska California Colorado Florida Georgia Illinois Kentucky Michigan Ohio Pennsylvania Texas Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1728-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.