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.
7 linked reportsMalfunction 7
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.87 |
| 2019-02 | 0 | 2.72 |
| 2019-03 | 0 | 2.96 |
| 2019-04 | 0 | 2.34 |
| 2019-05 | 0 | 3.5 |
| 2019-06 | 0 | 3.07 |
| 2019-07 | 0 | 4.67 |
| 2019-08 | 0 | 2.58 |
| 2019-09 | 0 | 2.32 |
| 2019-10 | 0 | 2.89 |
| 2019-11 | 0 | 3.66 |
| 2019-12 | 0 | 3.36 |
| 2020-01 | 0 | 2.58 |
| 2020-02 | 0 | 3.61 |
| 2020-03 | 0 | 3.57 |
| 2020-04 | 0 | 2.66 |
| 2020-05 | 0 | 4.78 |
| 2020-06 | 0 | 3.05 |
| 2020-07 | 0 | 7.65 |
| 2020-08 | 0 | 4.6 |
| 2020-09 | 0 | 4.93 |
| 2020-10 | 0 | 5.16 |
| 2020-11 | 0 | 5.22 |
| 2020-12 | 0 | 6.96 |
| 2021-01 | 0 | 7.7 |
| 2021-02 | 0 | 8.54 |
| 2021-03 | 0 | 11.25 |
| 2021-04 | 0 | 8.47 |
| 2021-05 | 0 | 7.84 |
| 2021-06 | 0 | 7.66 |
| 2021-07 | 0 | 6.83 |
| 2021-08 | 0 | 6.6 |
| 2021-09 | 0 | 10.21 |
| 2021-10 | 0 | 7.58 |
| 2021-11 | 0 | 9.04 |
| 2021-12 | 0 | 11.07 |
| 2022-01 | 0 | 7.83 |
| 2022-02 | 0 | 12.36 |
| 2022-03 | 0 | 10.63 |
| 2022-04 | 0 | 11.37 |
| 2022-05 | 0 | 11.04 |
| 2022-06 | 0 | 12.57 |
| 2022-07 | 0 | 9.38 |
| 2022-08 | 0 | 9.12 |
| 2022-09 | 0 | 10.89 |
| 2022-10 | 0 | 11.28 |
| 2022-11 | 2 | 9.71 |
| 2022-12 | 0 | 10.9 |
| 2023-01 | 0 | 9.57 |
| 2023-02 | 0 | 9.61 |
| 2023-03 | 0 | 11.7 |
| 2023-04 | 0 | 12.12 |
| 2023-05 | 0 | 10.43 |
| 2023-06 | 0 | 10.88 |
| 2023-07 | 0 | 13.01 |
| 2023-08 | 0 | 11.75 |
| 2023-09 | 0 | 10.87 |
| 2023-10 | 0 | 13.42 |
| 2023-11 | 0 | 13.96 |
| 2023-12 | 0 | 12.2 |
| 2024-01 | 2 | 11.83 |
| 2024-02 | 0 | 12.29 |
| 2024-03 | 0 | 14.75 |
| 2024-04 | 0 | 11.63 |
| 2024-05 | 0 | 10.75 |
| 2024-06 | 0 | 11.37 |
| 2024-07 | 0 | 11.58 |
| 2024-08 | 0 | 9.35 |
| 2024-09 | 0 | 10.02 |
| 2024-10 | 0 | 12.57 |
| 2024-11 | 0 | 7.01 |
| 2024-12 | 0 | 4.92 |
| 2025-01 | 0 | 6.15 |
| 2025-02 | 0 | 5.52 |
| 2025-03 | 0 | 6.71 |
| 2025-04 | 0 | 7.18 |
| 2025-05 | 0 | 8.77 |
| 2025-06 | 0 | 8.46 |
| 2025-07 | 0 | 8.25 |
| 2025-08 | 0 | 9.83 |
| 2025-09 | 0 | 6.72 |
| 2025-10 | 0 | 13.32 |
| 2025-11 | 0 | 22.15 |
| 2025-12 | 1 | 47.11 |
| 2026-01 | 0 | 36.87 |
| 2026-02 | 0 | 22.32 |
| 2026-03 | 0 | 21.97 |
| 2026-04 | 2 | 28.1 |
| 2026-05 | 0 | 32.9 |
| 2026-06 | 0 | 33.73 |
Failure-mode summaryAI-generated
7 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-15 | 3005099803-2026-01383 | Malfunction | Available | exact di |
| 2025-12-11 | 23777576 | Malfunction | Available | model number |
| 2024-01-09 | 3005099803-2023-07100 | Malfunction | Available | exact di |
| 2022-11-22 | 3005099803-2022-06740 | Malfunction | Available | exact di |
Showing the most recent 4 of 7 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-04-07 | OAI | Official action indicated | Boston Scientific Corporation | 9 |
| 2025-04-07 | OAI | Official action indicated | Boston Scientific Corporation | 9 |
| 2025-03-18 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2025-03-18 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2024-12-06 | NAI | No action indicated | Nalu Medical, Inc. | 0 |
| 2024-11-26 | VAI | Voluntary action indicated | Boston Scientific Corporation | 3 |
| 2024-11-26 | VAI | Voluntary action indicated | Boston Scientific Corporation | 3 |
| 2024-06-13 | NAI | No action indicated | Elutia Inc | 0 |
| 2024-01-23 | VAI | Voluntary action indicated | Silk Road Medical | 1 |
| 2023-12-05 | NAI | No action indicated | Valencia Technologies Corporation | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Corbin Clinical Resources, Llc | 1 |
| 2023-08-01 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2023-08-01 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2023-04-05 | NAI | No action indicated | Intera Oncology, Inc. | 0 |
| 2022-07-28 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2022-07-28 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2022-06-02 | VAI | Voluntary action indicated | Boston Scientific de Costa Rica SRL | 0 |
| 2022-03-23 | NAI | No action indicated | Axonics, Inc. | 0 |
| 2021-11-17 | VAI | Voluntary action indicated | Valencia Technologies Corporation | 1 |
| 2021-10-29 | NAI | No action indicated | Boston Scientific Corporation | 0 |
| 2014-04-10 | WL | Warning Letter | Boston Scientific Corporation | — |
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