FDA Device recall Z-2327-2026
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930 by Inspiremd, citing stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2327-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-01 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Inspiremd |
| Distribution | US |
Product
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
Reason
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Identifiers
| code_info | UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2327-2026%22
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