Inari Medical - Oak Canyon: Artix MT Thrombectomy Device, REF: 32-102

Hazard

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.

Details from the source

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: US Nationwide distribution in the states of FL, IL, WI, KY, TX, CA, OH, GA, AK, MI, PA, WA, CO, OH. Quantity: 45 Lot/code info: UDI-DI: 00810123710584, Lot: 24100082, Expiration: 14 April 2025. IFU: IU-01087 Rev. B

UPC codes

00810123710584

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.