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ENROUTE Transcarotid Stent
Model SR-0940-CS · Silk Road Medical, Inc. · DI 00811311020508
NIM — Stent, Carotid · Class III
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (1)
Initiated
Recall #
Class
Status
Reason
Link basis
2021-01-13
Z-1146-2021
Class II
Terminated
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
code info di
Adverse-event reports — MAUDE (175)
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: 150 · Malfunction: 15 · Death: 10
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
3
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
6
3.5
2020-03
0
2.67
2020-04
3
2.25
2020-05
0
2
2020-06
0
2.2
2020-07
3
4.5
2020-08
5
3
2020-09
0
3.25
2020-10
3
3
2020-11
3
2.44
2020-12
3
3
2021-01
6
3
2021-02
8
5
2021-03
0
4.33
2021-04
6
3.14
2021-05
0
2.6
2021-06
0
3.6
2021-07
3
4
2021-08
0
2.6
2021-09
0
2.5
2021-10
6
4
2021-11
3
3
2021-12
3
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
4
2.78
2022-07
3
3.17
2022-08
0
3.67
2022-09
0
3.8
2022-10
0
2.67
2022-11
4
3.2
2022-12
0
3
2023-01
0
4
2023-02
3
2.6
2023-03
0
2.6
2023-04
0
4
2023-05
3
2.29
2023-06
0
2.75
2023-07
0
2.29
2023-08
0
2.6
2023-09
0
2.29
2023-10
6
4.25
2023-11
0
4.4
2023-12
3
2.25
2024-01
3
1.33
2024-02
2
3
2024-03
9
2.75
2024-04
9
3.5
2024-05
9
3.42
2024-06
3
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
2
2.5
2025-03
0
2.22
2025-04
0
3.25
2025-05
3
3.13
2025-06
3
3.56
2025-07
6
4.21
2025-08
0
3.5
2025-09
3
3.54
2025-10
3
2.84
2025-11
6
2.89
2025-12
3
2.18
2026-01
3
3.68
2026-02
6
4
2026-03
3
2.53
2026-04
0
2.88
2026-05
3
2.84
2026-06
6
5.37
This device (reports/month)Average device in NIM (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Silk Road Medical, Inc.
VAI 2024-01-23 Silk Road Medical · 1 citations
NAI 2023-10-18 Silk Road Medical Inc · 0 citations
VAI 2020-02-27 Silk Road Medical Inc · 1 citations
NAI 2016-10-03 Silk Road Medical Inc · 0 citations
NAI 2016-06-23 Silk Road Medical Inc · 0 citations
VAI 2015-04-14 Silk Road Medical Inc · 1 citations
NAI 2014-07-11 Silk Road Medical Inc · 0 citations