Z-1728-2025 Class II Ongoing
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