Device product
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Z-2330-2026
Product summary
- Firm
- INSPIREMD Inc
- Event
- Event 98922
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 211 units
- Official record key
device-enforcement:Z-2330-2026
Official wording
Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Code information: UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Distribution pattern: 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.
Derived failure modes
-
Unknown
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.