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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.

164 linked reportsInjury 153Malfunction 8Death 3
369122019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 1/device2019-03: 3 reports for this device; peer average 2.75/device2019-04: 3 reports for this device; peer average 3/device2019-05: 0 reports for this device; peer average 2.67/device2019-06: 3 reports for this device; peer average 2/device2019-07: 3 reports for this device; peer average 2.88/device2019-08: 0 reports for this device; peer average 2.25/device2019-09: 6 reports for this device; peer average 2.83/device2019-10: 0 reports for this device; peer average 2/device2019-11: 3 reports for this device; peer average 2.67/device2019-12: 0 reports for this device; peer average 3/device2020-01: 3 reports for this device; peer average 3.25/device2020-02: 0 reports for this device; peer average 3.5/device2020-03: 0 reports for this device; peer average 2.67/device2020-04: 0 reports for this device; peer average 2.25/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.2/device2020-07: 0 reports for this device; peer average 4.5/device2020-08: 0 reports for this device; peer average 3/device2020-09: 5 reports for this device; peer average 3.25/device2020-10: 3 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 2.44/device2020-12: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 3/device2021-02: 6 reports for this device; peer average 5/device2021-03: 6 reports for this device; peer average 4.33/device2021-04: 0 reports for this device; peer average 3.14/device2021-05: 3 reports for this device; peer average 2.6/device2021-06: 0 reports for this device; peer average 3.6/device2021-07: 0 reports for this device; peer average 4/device2021-08: 0 reports for this device; peer average 2.6/device2021-09: 0 reports for this device; peer average 2.5/device2021-10: 0 reports for this device; peer average 4/device2021-11: 3 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 2.2/device2022-01: 0 reports for this device; peer average 3/device2022-02: 3 reports for this device; peer average 2.82/device2022-03: 6 reports for this device; peer average 6/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 3.5/device2022-06: 3 reports for this device; peer average 2.78/device2022-07: 6 reports for this device; peer average 3.17/device2022-08: 0 reports for this device; peer average 3.67/device2022-09: 3 reports for this device; peer average 3.8/device2022-10: 0 reports for this device; peer average 2.67/device2022-11: 0 reports for this device; peer average 3.2/device2022-12: 3 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 4/device2023-02: 0 reports for this device; peer average 2.6/device2023-03: 1 reports for this device; peer average 2.6/device2023-04: 3 reports for this device; peer average 4/device2023-05: 3 reports for this device; peer average 2.29/device2023-06: 0 reports for this device; peer average 2.75/device2023-07: 3 reports for this device; peer average 2.29/device2023-08: 0 reports for this device; peer average 2.6/device2023-09: 3 reports for this device; peer average 2.29/device2023-10: 6 reports for this device; peer average 4.25/device2023-11: 12 reports for this device; peer average 4.4/device2023-12: 0 reports for this device; peer average 2.25/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 2 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 2.75/device2024-04: 0 reports for this device; peer average 3.5/device2024-05: 3 reports for this device; peer average 3.42/device2024-06: 0 reports for this device; peer average 3.4/device2024-07: 0 reports for this device; peer average 2.5/device2024-08: 2 reports for this device; peer average 3/device2024-09: 4 reports for this device; peer average 2.75/device2024-10: 0 reports for this device; peer average 1.67/device2024-11: 0 reports for this device; peer average 4.27/device2024-12: 2 reports for this device; peer average 2.33/device2025-01: 0 reports for this device; peer average 2.08/device2025-02: 0 reports for this device; peer average 2.5/device2025-03: 4 reports for this device; peer average 2.22/device2025-04: 0 reports for this device; peer average 3.25/device2025-05: 6 reports for this device; peer average 3.13/device2025-06: 9 reports for this device; peer average 3.56/device2025-07: 0 reports for this device; peer average 4.21/device2025-08: 0 reports for this device; peer average 3.5/device2025-09: 0 reports for this device; peer average 3.54/device2025-10: 12 reports for this device; peer average 2.84/device2025-11: 0 reports for this device; peer average 2.89/device2025-12: 0 reports for this device; peer average 2.18/device2026-01: 0 reports for this device; peer average 3.68/device2026-02: 3 reports for this device; peer average 4/device2026-03: 0 reports for this device; peer average 2.53/device2026-04: 3 reports for this device; peer average 2.88/device2026-05: 6 reports for this device; peer average 2.84/device2026-06: 3 reports for this device; peer average 5.37/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0201
2019-0332.75
2019-0433
2019-0502.67
2019-0632
2019-0732.88
2019-0802.25
2019-0962.83
2019-1002
2019-1132.67
2019-1203
2020-0133.25
2020-0203.5
2020-0302.67
2020-0402.25
2020-0502
2020-0602.2
2020-0704.5
2020-0803
2020-0953.25
2020-1033
2020-1102.44
2020-1203
2021-0103
2021-0265
2021-0364.33
2021-0403.14
2021-0532.6
2021-0603.6
2021-0704
2021-0802.6
2021-0902.5
2021-1004
2021-1133
2021-1202.2
2022-0103
2022-0232.82
2022-0366
2022-0403
2022-0503.5
2022-0632.78
2022-0763.17
2022-0803.67
2022-0933.8
2022-1002.67
2022-1103.2
2022-1233
2023-0104
2023-0202.6
2023-0312.6
2023-0434
2023-0532.29
2023-0602.75
2023-0732.29
2023-0802.6
2023-0932.29
2023-1064.25
2023-11124.4
2023-1202.25
2024-0101.33
2024-0223
2024-0302.75
2024-0403.5
2024-0533.42
2024-0603.4
2024-0702.5
2024-0823
2024-0942.75
2024-1001.67
2024-1104.27
2024-1222.33
2025-0102.08
2025-0202.5
2025-0342.22
2025-0403.25
2025-0563.13
2025-0693.56
2025-0704.21
2025-0803.5
2025-0903.54
2025-10122.84
2025-1102.89
2025-1202.18
2026-0103.68
2026-0234
2026-0302.53
2026-0432.88
2026-0562.84
2026-0635.37
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
DateReport #TypeNarrativeLink basis
2026-06-092124215-2026-30820InjuryAvailablecatalog number
2026-05-262124215-2026-28178InjuryAvailablecatalog number
2026-05-202124215-2026-27252InjuryAvailablecatalog number
2026-04-232124215-2026-22040InjuryAvailablecatalog number
2026-02-042124215-2026-06501InjuryAvailablecatalog number
2025-10-292124215-2025-75796InjuryAvailablecatalog number
2025-10-232124215-2025-75229InjuryAvailablecatalog number
2025-10-152124215-2025-72335InjuryAvailablecatalog number
2025-10-152124215-2025-71992MalfunctionAvailablecatalog number
2025-06-192124215-2025-40306InjuryAvailablecatalog number
2025-06-062124215-2025-37092InjuryAvailablecatalog number
2025-06-052124215-2025-36823InjuryAvailablecatalog number
2025-05-232124215-2025-33476InjuryAvailablecatalog number
2025-05-162124215-2025-31530InjuryAvailablecatalog number
2025-03-193014526664-2025-00050InjuryAvailablecatalog number

Showing the most recent 58 of 164 linked reports.

Showing 1–15 of 58
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2024-01-23VAIVoluntary action indicatedSilk Road Medical1
2023-10-18NAINo action indicatedSilk Road Medical Inc0
2020-02-27VAIVoluntary action indicatedSilk Road Medical Inc1
2016-10-03NAINo action indicatedSilk Road Medical Inc0
2016-06-23NAINo action indicatedSilk Road Medical Inc0
2015-04-14VAIVoluntary action indicatedSilk Road Medical Inc1
2014-07-11NAINo action indicatedSilk Road Medical Inc0
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