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Recall Category: Medical Device Recalls
Recalling Firm: INSPIREMD Inc
Product: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Reason for Recall: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Classification: Class II
Status: Ongoing
Report Date: 06/17/2026
Recall Initiation Date: 05/01/2026
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.
Code Info: UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Product Quantity: 424 units
Recall Type: Voluntary: Firm initiated
Initial Firm Notification: E-Mail
Firm Location: Miami, FL, United States
Recall Number: Z-2326-2026
Event ID: 98922