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.
229 linked reportsMalfunction 126Injury 101Death 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.64 |
| 2019-02 | 0 | 1.52 |
| 2019-03 | 1 | 1.78 |
| 2019-04 | 0 | 1.69 |
| 2019-05 | 1 | 1.69 |
| 2019-06 | 1 | 1.57 |
| 2019-07 | 1 | 2.02 |
| 2019-08 | 0 | 2.38 |
| 2019-09 | 0 | 2.08 |
| 2019-10 | 0 | 2.24 |
| 2019-11 | 0 | 2.03 |
| 2019-12 | 0 | 2.52 |
| 2020-01 | 0 | 2.3 |
| 2020-02 | 0 | 2.95 |
| 2020-03 | 1 | 2.85 |
| 2020-04 | 0 | 2.16 |
| 2020-05 | 0 | 2.68 |
| 2020-06 | 0 | 2.49 |
| 2020-07 | 3 | 2.84 |
| 2020-08 | 0 | 2.54 |
| 2020-09 | 0 | 2.44 |
| 2020-10 | 0 | 2.65 |
| 2020-11 | 1 | 2.68 |
| 2020-12 | 0 | 2.75 |
| 2021-01 | 0 | 3.03 |
| 2021-02 | 1 | 2.16 |
| 2021-03 | 0 | 2.69 |
| 2021-04 | 0 | 2.62 |
| 2021-05 | 0 | 2.05 |
| 2021-06 | 3 | 2.42 |
| 2021-07 | 2 | 3.07 |
| 2021-08 | 0 | 2.39 |
| 2021-09 | 0 | 2.41 |
| 2021-10 | 0 | 2.02 |
| 2021-11 | 0 | 2.34 |
| 2021-12 | 2 | 2.64 |
| 2022-01 | 2 | 2.63 |
| 2022-02 | 3 | 2.35 |
| 2022-03 | 3 | 2.36 |
| 2022-04 | 1 | 2.61 |
| 2022-05 | 9 | 2.86 |
| 2022-06 | 14 | 2.75 |
| 2022-07 | 7 | 2.57 |
| 2022-08 | 9 | 3.01 |
| 2022-09 | 4 | 2.56 |
| 2022-10 | 7 | 2.26 |
| 2022-11 | 3 | 2.62 |
| 2022-12 | 5 | 2.42 |
| 2023-01 | 7 | 1.86 |
| 2023-02 | 1 | 2.64 |
| 2023-03 | 7 | 2.56 |
| 2023-04 | 3 | 2.25 |
| 2023-05 | 14 | 2.99 |
| 2023-06 | 8 | 2.39 |
| 2023-07 | 9 | 2.63 |
| 2023-08 | 4 | 2.65 |
| 2023-09 | 3 | 2.76 |
| 2023-10 | 6 | 2.54 |
| 2023-11 | 1 | 2.64 |
| 2023-12 | 0 | 2.8 |
| 2024-01 | 3 | 2.65 |
| 2024-02 | 11 | 2.63 |
| 2024-03 | 6 | 2.81 |
| 2024-04 | 3 | 2.26 |
| 2024-05 | 5 | 3.29 |
| 2024-06 | 4 | 3.05 |
| 2024-07 | 7 | 2.31 |
| 2024-08 | 6 | 3.62 |
| 2024-09 | 2 | 3.04 |
| 2024-10 | 3 | 4.01 |
| 2024-11 | 6 | 3.37 |
| 2024-12 | 0 | 3.81 |
| 2025-01 | 6 | 2.98 |
| 2025-02 | 7 | 3.19 |
| 2025-03 | 6 | 3.22 |
| 2025-04 | 5 | 3.49 |
| 2025-05 | 1 | 3.33 |
| 2025-06 | 0 | 2.89 |
| 2025-07 | 1 | 3.12 |
| 2025-08 | 0 | 3.21 |
| 2025-09 | 0 | 3.5 |
| 2025-10 | 0 | 3.24 |
| 2025-11 | 0 | 3.94 |
| 2025-12 | 0 | 4.49 |
| 2026-01 | 0 | 3.58 |
| 2026-02 | 0 | 3.79 |
| 2026-03 | 0 | 3.9 |
| 2026-04 | 0 | 2.99 |
| 2026-05 | 0 | 2.69 |
| 2026-06 | 0 | 2.84 |
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 |
|---|---|---|---|---|
| 2025-07-17 | 3006010712-2025-00032 | Malfunction | Available | exact di |
| 2025-05-21 | 3006010712-2025-00025 | Malfunction | Available | exact di |
| 2025-04-25 | 3006010712-2025-00022 | Malfunction | Available | exact di |
| 2025-04-09 | 3006010712-2025-00020 | Injury | Available | exact di |
| 2025-04-02 | 3006010712-2025-00019 | Malfunction | Available | exact di |
| 2025-04-01 | 3006010712-2025-00016 | Malfunction | Available | exact di |
| 2025-04-01 | 3006010712-2025-00017 | Malfunction | Available | exact di |
| 2025-03-27 | 3014526664-2025-00053 | Injury | Available | exact di |
| 2025-03-27 | 3014526664-2025-00054 | Injury | Available | exact di |
| 2025-03-14 | 3014526664-2025-00046 | Injury | Available | exact di |
| 2025-03-10 | 3014526664-2025-00042 | Injury | Available | exact di |
| 2025-03-04 | 3006010712-2025-00011 | Malfunction | Available | exact di |
| 2025-03-03 | 3014526664-2025-00035 | Injury | Available | exact di |
| 2025-02-11 | 3014526664-2025-00017 | Injury | Available | exact di |
| 2025-02-11 | 3006010712-2025-00009 | Malfunction | Available | exact di |
Showing the most recent 200 of 229 linked reports.
Showing 1–15 of 200
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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