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.
31 linked reportsInjury 16Malfunction 15
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.92 |
| 2019-02 | 0 | 3.4 |
| 2019-03 | 0 | 5.26 |
| 2019-04 | 0 | 17.61 |
| 2019-05 | 0 | 3.59 |
| 2019-06 | 0 | 3.7 |
| 2019-07 | 0 | 3.43 |
| 2019-08 | 0 | 4.5 |
| 2019-09 | 0 | 2.91 |
| 2019-10 | 0 | 2.94 |
| 2019-11 | 0 | 2.63 |
| 2019-12 | 0 | 3.57 |
| 2020-01 | 0 | 2.96 |
| 2020-02 | 2 | 4 |
| 2020-03 | 2 | 2.04 |
| 2020-04 | 0 | 3 |
| 2020-05 | 0 | 2.22 |
| 2020-06 | 0 | 2.94 |
| 2020-07 | 1 | 2.76 |
| 2020-08 | 0 | 2.85 |
| 2020-09 | 1 | 2.72 |
| 2020-10 | 0 | 3.71 |
| 2020-11 | 0 | 3.87 |
| 2020-12 | 0 | 4.54 |
| 2021-01 | 0 | 3.76 |
| 2021-02 | 0 | 3.35 |
| 2021-03 | 0 | 4.73 |
| 2021-04 | 2 | 3.98 |
| 2021-05 | 0 | 4.17 |
| 2021-06 | 0 | 3.73 |
| 2021-07 | 0 | 2.93 |
| 2021-08 | 0 | 3.6 |
| 2021-09 | 1 | 3.63 |
| 2021-10 | 0 | 4.16 |
| 2021-11 | 0 | 3.38 |
| 2021-12 | 2 | 4.08 |
| 2022-01 | 0 | 4.49 |
| 2022-02 | 0 | 3.86 |
| 2022-03 | 0 | 5.03 |
| 2022-04 | 0 | 5.31 |
| 2022-05 | 0 | 4.94 |
| 2022-06 | 2 | 5.11 |
| 2022-07 | 0 | 5.55 |
| 2022-08 | 0 | 5.03 |
| 2022-09 | 0 | 4.62 |
| 2022-10 | 2 | 4.83 |
| 2022-11 | 0 | 4.88 |
| 2022-12 | 0 | 5.31 |
| 2023-01 | 0 | 6.68 |
| 2023-02 | 2 | 5.07 |
| 2023-03 | 1 | 6.59 |
| 2023-04 | 2 | 5.33 |
| 2023-05 | 2 | 5.91 |
| 2023-06 | 0 | 5.64 |
| 2023-07 | 0 | 5.44 |
| 2023-08 | 2 | 6.21 |
| 2023-09 | 0 | 5.98 |
| 2023-10 | 0 | 5.97 |
| 2023-11 | 2 | 6.16 |
| 2023-12 | 0 | 6.09 |
| 2024-01 | 0 | 5.57 |
| 2024-02 | 0 | 5.24 |
| 2024-03 | 0 | 6.05 |
| 2024-04 | 1 | 5.34 |
| 2024-05 | 0 | 5.52 |
| 2024-06 | 0 | 6.23 |
| 2024-07 | 0 | 5.16 |
| 2024-08 | 0 | 7 |
| 2024-09 | 0 | 6.11 |
| 2024-10 | 0 | 7.06 |
| 2024-11 | 0 | 8.75 |
| 2024-12 | 0 | 3.74 |
| 2025-01 | 0 | 4.75 |
| 2025-02 | 0 | 3.62 |
| 2025-03 | 0 | 3.78 |
| 2025-04 | 0 | 4.29 |
| 2025-05 | 0 | 4.11 |
| 2025-06 | 0 | 4.94 |
| 2025-07 | 0 | 4.62 |
| 2025-08 | 0 | 4.65 |
| 2025-09 | 0 | 4.18 |
| 2025-10 | 2 | 4.91 |
| 2025-11 | 0 | 5.66 |
| 2025-12 | 0 | 8.15 |
| 2026-01 | 0 | 7.15 |
| 2026-02 | 2 | 7.1 |
| 2026-03 | 0 | 5.68 |
| 2026-04 | 0 | 7.25 |
| 2026-05 | 0 | 8.25 |
| 2026-06 | 0 | 6.61 |
Failure-mode summaryAI-generated
31 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-27 | 3005099803-2026-00760 | Malfunction | Available | exact di |
| 2025-10-10 | 3005099803-2025-04925 | Malfunction | Available | model number |
| 2025-10-07 | 3005099803-2025-04820 | Malfunction | Available | model number |
| 2024-04-15 | 3005099803-2024-01718 | Malfunction | Available | model number |
| 2023-11-21 | 3005099803-2023-06302 | Injury | Available | exact di |
| 2023-08-11 | 3005099803-2023-04193 | Injury | Available | exact di |
| 2023-05-08 | 3005099803-2023-02315 | Injury | Available | exact di |
| 2023-04-24 | 3005099803-2023-02056 | Injury | Available | exact di |
| 2023-03-30 | 16643464 | Malfunction | Available | model number |
| 2023-02-13 | 3005099803-2023-00334 | Injury | Available | exact di |
| 2022-10-13 | 3005099803-2022-05779 | Malfunction | Available | exact di |
| 2022-06-13 | 3005099803-2022-03082 | Malfunction | Available | exact di |
| 2021-12-03 | 3005099803-2021-05993 | Injury | Available | exact di |
| 2021-09-02 | 3005099803-2021-04401 | Injury | Available | exact di |
| 2021-04-15 | 3005099803-2021-01542 | Malfunction | Available | exact di |
Showing the most recent 20 of 31 linked reports.
Showing 1–15 of 20
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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