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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.

1,417 linked reportsInjury 1,390Malfunction 21Death 6
102029392019-01: 0 reports for this device; peer average 1.33/device2019-02: 2 reports for this device; peer average 1.6/device2019-03: 18 reports for this device; peer average 8.8/device2019-04: 6 reports for this device; peer average 2.5/device2019-05: 15 reports for this device; peer average 5.43/device2019-06: 8 reports for this device; peer average 3.5/device2019-07: 16 reports for this device; peer average 7/device2019-08: 8 reports for this device; peer average 3.33/device2019-09: 16 reports for this device; peer average 6.5/device2019-10: 10 reports for this device; peer average 4.38/device2019-11: 7 reports for this device; peer average 5/device2019-12: 2 reports for this device; peer average 3/device2020-01: 39 reports for this device; peer average 26.25/device2020-02: 12 reports for this device; peer average 9.5/device2020-03: 12 reports for this device; peer average 6.8/device2020-04: 4 reports for this device; peer average 2.57/device2020-05: 4 reports for this device; peer average 5.67/device2020-06: 6 reports for this device; peer average 3.5/device2020-07: 12 reports for this device; peer average 5.11/device2020-08: 4 reports for this device; peer average 5/device2020-09: 12 reports for this device; peer average 8/device2020-10: 5 reports for this device; peer average 3.13/device2020-11: 11 reports for this device; peer average 7.29/device2020-12: 10 reports for this device; peer average 9.67/device2021-01: 10 reports for this device; peer average 6.2/device2021-02: 13 reports for this device; peer average 7.17/device2021-03: 18 reports for this device; peer average 11.5/device2021-04: 30 reports for this device; peer average 12/device2021-05: 20 reports for this device; peer average 8.33/device2021-06: 32 reports for this device; peer average 13.17/device2021-07: 26 reports for this device; peer average 11.17/device2021-08: 22 reports for this device; peer average 13/device2021-09: 20 reports for this device; peer average 10.33/device2021-10: 30 reports for this device; peer average 11.33/device2021-11: 26 reports for this device; peer average 16.2/device2021-12: 22 reports for this device; peer average 12.4/device2022-01: 25 reports for this device; peer average 15.2/device2022-02: 10 reports for this device; peer average 9.6/device2022-03: 27 reports for this device; peer average 9.86/device2022-04: 14 reports for this device; peer average 7.67/device2022-05: 28 reports for this device; peer average 23.67/device2022-06: 22 reports for this device; peer average 11.2/device2022-07: 24 reports for this device; peer average 13.8/device2022-08: 26 reports for this device; peer average 11.63/device2022-09: 24 reports for this device; peer average 10.83/device2022-10: 20 reports for this device; peer average 8.71/device2022-11: 30 reports for this device; peer average 12.5/device2022-12: 24 reports for this device; peer average 13/device2023-01: 19 reports for this device; peer average 6/device2023-02: 24 reports for this device; peer average 11.67/device2023-03: 29 reports for this device; peer average 14.8/device2023-04: 30 reports for this device; peer average 16.5/device2023-05: 20 reports for this device; peer average 11.2/device2023-06: 20 reports for this device; peer average 8.5/device2023-07: 33 reports for this device; peer average 17/device2023-08: 19 reports for this device; peer average 6.38/device2023-09: 29 reports for this device; peer average 14.6/device2023-10: 30 reports for this device; peer average 17.25/device2023-11: 29 reports for this device; peer average 12.2/device2023-12: 30 reports for this device; peer average 13.5/device2024-01: 34 reports for this device; peer average 13.83/device2024-02: 24 reports for this device; peer average 17.5/device2024-03: 28 reports for this device; peer average 11.5/device2024-04: 24 reports for this device; peer average 10/device2024-05: 27 reports for this device; peer average 14.4/device2024-06: 20 reports for this device; peer average 8.86/device2024-07: 19 reports for this device; peer average 10.57/device2024-08: 19 reports for this device; peer average 9.29/device2024-09: 26 reports for this device; peer average 9/device2024-10: 21 reports for this device; peer average 6.89/device2024-11: 20 reports for this device; peer average 10.5/device2024-12: 7 reports for this device; peer average 4/device2025-01: 10 reports for this device; peer average 7.14/device2025-02: 10 reports for this device; peer average 5.17/device2025-03: 10 reports for this device; peer average 6/device2025-04: 9 reports for this device; peer average 5.75/device2025-05: 1 reports for this device; peer average 4.17/device2025-06: 4 reports for this device; peer average 8.33/device2025-07: 0 reports for this device; peer average 5/device2025-08: 0 reports for this device; peer average 5/device2025-09: 0 reports for this device; peer average 4.86/device2025-10: 0 reports for this device; peer average 7/device2025-11: 0 reports for this device; peer average 5.2/device2025-12: 0 reports for this device; peer average 4.7/device2026-01: 0 reports for this device; peer average 10.5/device2026-02: 0 reports for this device; peer average 3.33/device2026-03: 0 reports for this device; peer average 6.38/device2026-04: 0 reports for this device; peer average 4.25/device2026-05: 9 reports for this device; peer average 6.88/device2026-06: 1 reports for this device; peer average 3.63/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.33
2019-0221.6
2019-03188.8
2019-0462.5
2019-05155.43
2019-0683.5
2019-07167
2019-0883.33
2019-09166.5
2019-10104.38
2019-1175
2019-1223
2020-013926.25
2020-02129.5
2020-03126.8
2020-0442.57
2020-0545.67
2020-0663.5
2020-07125.11
2020-0845
2020-09128
2020-1053.13
2020-11117.29
2020-12109.67
2021-01106.2
2021-02137.17
2021-031811.5
2021-043012
2021-05208.33
2021-063213.17
2021-072611.17
2021-082213
2021-092010.33
2021-103011.33
2021-112616.2
2021-122212.4
2022-012515.2
2022-02109.6
2022-03279.86
2022-04147.67
2022-052823.67
2022-062211.2
2022-072413.8
2022-082611.63
2022-092410.83
2022-10208.71
2022-113012.5
2022-122413
2023-01196
2023-022411.67
2023-032914.8
2023-043016.5
2023-052011.2
2023-06208.5
2023-073317
2023-08196.38
2023-092914.6
2023-103017.25
2023-112912.2
2023-123013.5
2024-013413.83
2024-022417.5
2024-032811.5
2024-042410
2024-052714.4
2024-06208.86
2024-071910.57
2024-08199.29
2024-09269
2024-10216.89
2024-112010.5
2024-1274
2025-01107.14
2025-02105.17
2025-03106
2025-0495.75
2025-0514.17
2025-0648.33
2025-0705
2025-0805
2025-0904.86
2025-1007
2025-1105.2
2025-1204.7
2026-01010.5
2026-0203.33
2026-0306.38
2026-0404.25
2026-0596.88
2026-0613.63
This device (reports/month)Average device in NTE (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
2026-06-012124215-2026-29264MalfunctionAvailablecatalog number
2026-05-142124215-2026-26215InjuryAvailablecatalog number
2026-05-112124215-2026-25392InjuryAvailablecatalog number
2026-05-112124215-2026-25387InjuryAvailablecatalog number
2026-05-112124215-2026-25389InjuryAvailablecatalog number
2026-05-112124215-2026-25393InjuryAvailablecatalog number
2026-05-112124215-2026-25394InjuryAvailablecatalog number
2026-05-112124215-2026-25388InjuryAvailablecatalog number
2026-05-112124215-2026-25395InjuryAvailablecatalog number
2026-05-112124215-2026-25381InjuryAvailablecatalog number
2025-06-172124215-2025-39413InjuryAvailablecatalog number
2025-06-122124215-2025-38234InjuryAvailablecatalog number
2025-06-122124215-2025-37644InjuryAvailablecatalog number
2025-06-112124215-2025-37651InjuryAvailablecatalog number
2025-05-222124215-2025-32695InjuryAvailablecatalog number

Showing the most recent 200 of 1,417 linked reports.

Showing 1–15 of 200
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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