FDAHealthMay 1, 2026
INSPIREMD Inc — Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
⚠️ Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 1, 2026
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.
What's affected?
- Product
- Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
- Brand
- INSPIREMD Inc
- Lot code
- /serial
Additional details
UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 291 units.
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