CGuard Prime Carotid Stent System
InspireMD recalls CGuard Prime Carotid Stent System (model CND0830) due to deployment complications.
Do not use the affected stent system. Contact InspireMD for instructions on returning the product and obtaining a replacement.
Why it was recalled
InspireMD is recalling the CGuard Prime Carotid Stent System, model CND0830, because the stent delivery system may encounter complications during deployment, resulting in high resistance or inability to deploy the stent.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Lot code: all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
| Product | Recall # | UDI-DI | Model/Catalog number |
|---|---|---|---|
| CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm | Z-2326-2026 | 07290120281707 | CND0840 |
| CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm | Z-2325-2026 | 07290120281691 | CND0830 |
| CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930 | Z-2327-2026 | 07290120281738 | – |
| CGuard Prime Carotid Stent System, 135cm, 9mx40mm | Z-2328-2026 | 07290120281745 | CND0940 |
| CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040 | Z-2330-2026 | 07290120281783 | – |
| CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030 | Z-2329-2026 | 07290120281776 | – |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-08 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification