Drug recall
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
FDA recall event 98922 · Class II · INSPIREMD Inc
Key facts
| Event ID | 98922 |
|---|---|
| Recall numbers | Z-2325-2026, Z-2326-2026, Z-2327-2026, Z-2328-2026, Z-2329-2026, Z-2330-2026 |
| Recalling firm | INSPIREMD Inc |
| Product type | Devices |
| Products | Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830, Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840, Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940, CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030, CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040 and 1 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. |
| Initiation date | May 1, 2026 |
| Report date | Jun 17, 2026 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3032814119 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: