INSPIREMD Inc recalls Brand Name: CGuard¿ Prime Carotid Stent System
- Recalling company
- INSPIREMD Inc
- Product
- Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
- Reason
- Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 1, 2026
- Reported
- Jun 17, 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.
- Status
- Ongoing
- Quantity
- 190 units
- Lot / codes
- UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
- Company location
- Miami, FL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2325-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2325-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.