ENROUTE Transcarotid Stent · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

47 linked reportsInjury 39Death 6Malfunction 2

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	2	1.67
2024-11	0	4.27
2024-12	0	2.33
2025-01	1	2.08
2025-02	0	2.5
2025-03	0	2.22
2025-04	0	3.25
2025-05	2	3.13
2025-06	3	3.56
2025-07	2	4.21
2025-08	4	3.5
2025-09	4	3.54
2025-10	2	2.84
2025-11	3	2.89
2025-12	1	2.18
2026-01	5	3.68
2026-02	4	4
2026-03	2	2.53
2026-04	3	2.88
2026-05	2	2.84
2026-06	7	5.37

This device (reports/month)Average device in NIM (reports/device/month)

Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-06-25	2124215-2026-34074	Injury	Available	exact di
2026-06-18	2124215-2026-32652	Injury	Available	model number
2026-06-17	2124215-2026-32408	Injury	Available	model number
2026-06-15	2124215-2026-31712	Injury	Available	model number
2026-06-09	2124215-2026-30828	Death	Available	model number
2026-06-02	2124215-2026-29468	Injury	Available	model number
2026-05-29	2124215-2026-29071	Injury	Available	model number
2026-05-11	2124215-2026-25418	Injury	Available	model number
2026-04-22	2124215-2026-21728	Injury	Available	model number
2026-04-20	2124215-2026-21349	Injury	Available	model number
2026-04-13	2124215-2026-19769	Injury	Available	model number
2026-03-31	2124215-2026-17689	Injury	Available	model number
2026-03-04	2124215-2026-12110	Injury	Available	model number
2026-02-27	2124215-2026-11059	Injury	Available	model number
2026-02-26	2124215-2026-10862	Injury	Available	model number

Showing the most recent 43 of 47 linked reports.

Showing 1–15 of 43

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2024-01-23	VAI	Voluntary action indicated	Silk Road Medical	1
2023-10-18	NAI	No action indicated	Silk Road Medical Inc	0
2020-02-27	VAI	Voluntary action indicated	Silk Road Medical Inc	1
2016-10-03	NAI	No action indicated	Silk Road Medical Inc	0
2016-06-23	NAI	No action indicated	Silk Road Medical Inc	0
2015-04-14	VAI	Voluntary action indicated	Silk Road Medical Inc	1
2014-07-11	NAI	No action indicated	Silk Road Medical Inc	0

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