Z-1728-2025 Class II Ongoing
FDA device recall Z-1728-2025 was initiated by Inari Medical - Oak Canyon on April 8, 2025 and is designated Class II. 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 forc… The recall status is ongoing. Affected quantity: 45.
Recall Details
- Product Type
- Devices
- Report Date
- May 14, 2025
- Initiation Date
- April 8, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45
Product Description
Artix MT Thrombectomy Device, REF: 32-102
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 Pattern
US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH.
Code Information
UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B