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.
99 linked reportsInjury 96Malfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 12.92 |
| 2019-02 | 1 | 14.35 |
| 2019-03 | 1 | 14.05 |
| 2019-04 | 2 | 18.63 |
| 2019-05 | 2 | 19.54 |
| 2019-06 | 3 | 20.19 |
| 2019-07 | 1 | 13.37 |
| 2019-08 | 0 | 11.15 |
| 2019-09 | 1 | 11.95 |
| 2019-10 | 5 | 9.58 |
| 2019-11 | 1 | 11.88 |
| 2019-12 | 0 | 14.46 |
| 2020-01 | 3 | 11.27 |
| 2020-02 | 1 | 12.22 |
| 2020-03 | 1 | 12.88 |
| 2020-04 | 2 | 10.44 |
| 2020-05 | 0 | 15.5 |
| 2020-06 | 0 | 12.21 |
| 2020-07 | 4 | 14.34 |
| 2020-08 | 0 | 12.98 |
| 2020-09 | 2 | 12.31 |
| 2020-10 | 2 | 12.61 |
| 2020-11 | 1 | 14.12 |
| 2020-12 | 2 | 12.64 |
| 2021-01 | 2 | 11.89 |
| 2021-02 | 3 | 14.14 |
| 2021-03 | 2 | 13.25 |
| 2021-04 | 3 | 13.21 |
| 2021-05 | 0 | 14.8 |
| 2021-06 | 1 | 18.26 |
| 2021-07 | 2 | 13.79 |
| 2021-08 | 0 | 17.29 |
| 2021-09 | 2 | 24.68 |
| 2021-10 | 1 | 14.32 |
| 2021-11 | 2 | 16.72 |
| 2021-12 | 0 | 12.67 |
| 2022-01 | 2 | 10.59 |
| 2022-02 | 0 | 13.53 |
| 2022-03 | 2 | 15.09 |
| 2022-04 | 0 | 12.75 |
| 2022-05 | 1 | 16.55 |
| 2022-06 | 0 | 15.68 |
| 2022-07 | 1 | 12.74 |
| 2022-08 | 0 | 13.73 |
| 2022-09 | 1 | 15.67 |
| 2022-10 | 1 | 18.18 |
| 2022-11 | 1 | 16.94 |
| 2022-12 | 2 | 16.56 |
| 2023-01 | 2 | 14 |
| 2023-02 | 0 | 12.62 |
| 2023-03 | 1 | 16.68 |
| 2023-04 | 3 | 14.38 |
| 2023-05 | 2 | 16.67 |
| 2023-06 | 0 | 24.22 |
| 2023-07 | 1 | 25.39 |
| 2023-08 | 0 | 21.23 |
| 2023-09 | 0 | 17.03 |
| 2023-10 | 0 | 17.29 |
| 2023-11 | 2 | 18.43 |
| 2023-12 | 1 | 20.54 |
| 2024-01 | 0 | 25.65 |
| 2024-02 | 1 | 20.49 |
| 2024-03 | 1 | 21.69 |
| 2024-04 | 0 | 22.32 |
| 2024-05 | 1 | 18.44 |
| 2024-06 | 0 | 19.81 |
| 2024-07 | 2 | 23.6 |
| 2024-08 | 2 | 29.73 |
| 2024-09 | 1 | 22.75 |
| 2024-10 | 1 | 27.4 |
| 2024-11 | 0 | 14.37 |
| 2024-12 | 0 | 16.74 |
| 2025-01 | 2 | 16.27 |
| 2025-02 | 1 | 21.38 |
| 2025-03 | 1 | 25.24 |
| 2025-04 | 1 | 23.34 |
| 2025-05 | 1 | 20.44 |
| 2025-06 | 0 | 33.41 |
| 2025-07 | 1 | 20.35 |
| 2025-08 | 0 | 17.63 |
| 2025-09 | 0 | 19.99 |
| 2025-10 | 0 | 18.6 |
| 2025-11 | 2 | 16.83 |
| 2025-12 | 0 | 15.93 |
| 2026-01 | 0 | 17 |
| 2026-02 | 0 | 14.12 |
| 2026-03 | 1 | 15.06 |
| 2026-04 | 0 | 11.52 |
| 2026-05 | 0 | 11.51 |
| 2026-06 | 3 | 8.95 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-08-31 | Z-0056-2021 | Class II | Terminated | Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width.Distribution: Worldwide distribution - US Nationwide distribution including in the states of Illinois, Massachusetts, Texas, California, Idaho, Missouri, Oregon, Connecticut and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Curacao, Czech Republic, Egypt, Finland, France, Germany, Switzerland, Netherlands, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kuwait, Malaysia, Myanmar, Norway, Pakistan, Romania, Slovakia, South Africa, Spain, Sweden, Thailand, Turkey and United Kingdom. | 271 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-10 | 8043933-2026-00039 | Injury | Available | exact di |
| 2026-06-03 | 8043933-2026-00036 | Injury | Available | exact di |
| 2026-03-04 | 8043933-2026-00013 | Injury | Available | exact di |
| 2025-11-27 | 8043933-2025-00088 | Injury | Available | exact di |
| 2025-11-24 | 8043933-2025-00086 | Injury | Available | exact di |
| 2025-07-16 | 8043933-2025-00053 | Injury | Available | exact di |
| 2025-05-15 | 8043933-2025-00039 | Injury | Available | exact di |
| 2025-04-17 | 8043933-2025-00026 | Injury | Available | exact di |
| 2025-03-07 | 8043933-2025-00016 | Injury | Available | exact di |
| 2025-02-07 | 8043933-2025-00008 | Injury | Available | exact di |
| 2025-01-09 | 8043933-2025-00002 | Injury | Available | exact di |
| 2025-01-09 | 8043933-2025-00001 | Injury | Available | exact di |
| 2024-10-17 | 8043933-2024-00061 | Injury | Available | exact di |
| 2024-09-05 | 8043933-2024-00050 | Injury | Available | exact di |
| 2024-08-22 | 8043933-2024-00046 | Injury | Available | exact di |
Showing the most recent 98 of 99 linked reports.
Showing 1–15 of 98
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
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