Recall archive / FDA device enforcement
Artix MT Thrombectomy Device, REF: 32-102 — FDA record Z-1728-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 8, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Artix MT Thrombectomy Device, REF: 32-102
- 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.
- Classification
- Class II
- Recalling firm
- Inari Medical - Oak Canyon
- Quantity
- 45
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1728-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 14, 2025
- Recall initiation date
- Apr 8, 2025
- Center classification date
- May 6, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.