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CGuard Prime Carotid Stent System CND1040

by InspireMD, Ltd. United States GUDID

Product code NIM

Regulatory status

as of 25 Oct 2026

Recall ongoing. 6 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290120281783 UDI-DIDate2 Jul 2025ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

6 recalls · 6 ongoing · FDA

  • 6 recalls, same reason

    • Ongoing Z-2326-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2325-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2327-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2330-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2328-2026 FDA Class II initiated 1 May 2026
    • Ongoing Z-2329-2026 FDA Class II initiated 1 May 2026

    Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Specification

GUDID · synced 22 Oct 2026

Trade Name
CGuard Prime Carotid Stent System
Generic Name
Mesh-sleeve carotid artery stent
Model / Ref / Catalog
CND1040
Primary DI / UDI-DI
07290120281783
PMA Number
FDA Product Code
NIM
GMDN Term
Mesh-sleeve carotid artery stent
Device Class
Class III
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Mesh-sleeve carotid artery stent

Cleared under the same submission (P240029)

Other devices from InspireMD, Ltd.

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (7)
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No

Sources (1)

  • FDA UDI 836716f7-be91-444a-b9e2-5b009725a5ea 35 fields · synced 22 Oct 2026