Inari Medical - Oak Canyon: Medical Device Recall in 2025 - (Recall #: Z-1728-2025)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2025.
Data Source: FDA.
Product Description:
Artix MT Thrombectomy Device, REF: 32-102
Product Classification:
Class II
Date Initiated: April 8, 2025
Date Posted: May 14, 2025
Recall Number: Z-1728-2025
Event ID: 96682
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.
Status: Ongoing
Product Quantity: 45
Code Information:
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B
Distribution Pattern:
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Voluntary or Mandated:
Voluntary: Firm initiated