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CGuard Prime Carotid Stent System
Model CND0840 · INSPIRE M.D LTD · DI 07290120281707
NIM — Stent, Carotid · Class III
UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (6)
Initiated
Recall #
Class
Status
Reason
Link basis
2026-05-01
Z-2325-2026
Class II
Open, Classified
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
k number procode
2026-05-01
Z-2326-2026
Class II
Open, Classified
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
code info di
2026-05-01
Z-2327-2026
Class II
Open, Classified
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
k number procode
2026-05-01
Z-2328-2026
Class II
Open, Classified
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
k number procode
2026-05-01
Z-2329-2026
Class II
Open, Classified
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
k number procode
2026-05-01
Z-2330-2026
Class II
Open, Classified
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
k number procode
Adverse-event reports — MAUDE (16)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 8 · Malfunction: 7 · Death: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.5
2019-02
0
1
2019-03
0
2.75
2019-04
0
3
2019-05
0
2.67
2019-06
0
2
2019-07
0
2.88
2019-08
0
2.25
2019-09
0
2.83
2019-10
0
2
2019-11
0
2.67
2019-12
0
3
2020-01
0
3.25
2020-02
0
3.5
2020-03
0
2.67
2020-04
0
2.25
2020-05
0
2
2020-06
0
2.2
2020-07
0
4.5
2020-08
0
3
2020-09
0
3.25
2020-10
0
3
2020-11
0
2.44
2020-12
0
3
2021-01
0
3
2021-02
0
5
2021-03
0
4.33
2021-04
0
3.14
2021-05
0
2.6
2021-06
0
3.6
2021-07
0
4
2021-08
0
2.6
2021-09
0
2.5
2021-10
0
4
2021-11
0
3
2021-12
0
2.2
2022-01
0
3
2022-02
0
2.82
2022-03
0
6
2022-04
0
3
2022-05
0
3.5
2022-06
0
2.78
2022-07
0
3.17
2022-08
0
3.67
2022-09
0
3.8
2022-10
0
2.67
2022-11
0
3.2
2022-12
0
3
2023-01
0
4
2023-02
0
2.6
2023-03
0
2.6
2023-04
0
4
2023-05
0
2.29
2023-06
0
2.75
2023-07
0
2.29
2023-08
0
2.6
2023-09
0
2.29
2023-10
0
4.25
2023-11
0
4.4
2023-12
0
2.25
2024-01
0
1.33
2024-02
0
3
2024-03
0
2.75
2024-04
0
3.5
2024-05
0
3.42
2024-06
0
3.4
2024-07
0
2.5
2024-08
0
3
2024-09
0
2.75
2024-10
0
1.67
2024-11
0
4.27
2024-12
0
2.33
2025-01
0
2.08
2025-02
0
2.5
2025-03
0
2.22
2025-04
0
3.25
2025-05
0
3.13
2025-06
0
3.56
2025-07
0
4.21
2025-08
0
3.5
2025-09
1
3.54
2025-10
1
2.84
2025-11
1
2.89
2025-12
2
2.18
2026-01
3
3.68
2026-02
5
4
2026-03
1
2.53
2026-04
2
2.88
2026-05
0
2.84
2026-06
0
5.37
This device (reports/month)Average device in NIM (reports/device/month)