CGuard¿ Prime Carotid Stent System — Class II medical device recall Z-2330-2026
Ongoing recall by INSPIREMD Inc, reported 2026-06-17, distributed nationwide. Stent delivery system may encounter complications during deployment which may result in high resistance or ina
| Recall number | Z-2330-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | INSPIREMD Inc, Miami, FL, United States |
| Recall initiated | 2026-05-01 |
| Classified | 2026-06-05 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 211 units |
| UPC / GTIN / UDI-DI | 07290120281783 |
| Model numbers | CND1040 |
Product
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Reason for recall
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2330-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.