INSPIREMD Inc: Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

Hazard

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Details from the source

Reason for recall: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Distribution: US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. Quantity: 291 units Lot/code info: UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

UPC codes

07290120281745

Source

Official record: FDA (Device enforcement) ↗

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