FDA Medical devices recall ·
CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model recall
- Recall number
- Z-2325-2026
- Date
- (initiated May 1, 2026)
- Company / brand
- INSPIREMD Inc
6303 Waterford District Dr Ste 215, Miami, FL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 190 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Why was it recalled?
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
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.
States: Arkansas Arizona California District of Columbia Florida Georgia Hawaii Illinois Indiana Kansas Massachusetts Maryland Michigan Missouri North Carolina New Jersey Nevada New York Ohio Oregon Rhode Island South Dakota Tennessee Texas Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2325-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.