FDA DevicesClass II
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1...
Published: June 17, 2026Recall ID: Z-2329-2026Category: devicesCountry: US
Reason for Recall / Hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Product Description & Identification
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Affected Products
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Additional Source Details
| Field | Value |
|---|---|
| City | Miami |
| State | FL |
| Event id | 98922 |
| Address 1 | 6303 Waterford District Dr Ste 215 |
| Address 2 | N/A |
| Code info | UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 |
| Postal code | 33126-6004 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 114 units |
| Reason for recall | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260501 |
| Initial firm notification | |
| Center classification date | 20260605 |
Overview
- Recalling FirmINSPIREMD Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS 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.