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.
42 linked reportsInjury 42
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-08 | 2 | 1.8 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 5 |
| 2020-06 | 2 | 2 |
| 2020-07 | 0 | 1.5 |
| 2020-08 | 6 | 6 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 2.5 |
| 2020-11 | 4 | 3.4 |
| 2020-12 | 0 | 1 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 1.33 |
| 2021-04 | 2 | 2 |
| 2021-05 | 0 | 2 |
| 2021-06 | 0 | 2 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 3 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1 |
| 2022-05 | 6 | 5 |
| 2022-06 | 0 | 2.2 |
| 2022-07 | 0 | 4 |
| 2022-08 | 0 | 3 |
| 2022-09 | 2 | 1.8 |
| 2022-10 | 0 | 2.29 |
| 2022-11 | 0 | 2 |
| 2022-12 | 0 | 1.17 |
| 2023-01 | 0 | 1.5 |
| 2023-02 | 0 | 3.33 |
| 2023-03 | 0 | 1.83 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1.33 |
| 2023-06 | 0 | 1.88 |
| 2023-07 | 2 | 2.19 |
| 2023-08 | 0 | 1.67 |
| 2023-09 | 2 | 6.43 |
| 2023-10 | 0 | 1.86 |
| 2023-11 | 2 | 1.68 |
| 2023-12 | 0 | 1.67 |
| 2024-01 | 2 | 1.64 |
| 2024-02 | 0 | 1.71 |
| 2024-03 | 2 | 1.83 |
| 2024-04 | 0 | 2.67 |
| 2024-05 | 0 | 2.5 |
| 2024-06 | 4 | 2.55 |
| 2024-07 | 0 | 2.57 |
| 2024-08 | 0 | 8.67 |
| 2024-09 | 0 | 2 |
| 2024-10 | 0 | 2.1 |
| 2024-11 | 0 | 1.44 |
| 2024-12 | 0 | 1.63 |
| 2025-01 | 0 | 3.55 |
| 2025-02 | 2 | 1.86 |
| 2025-03 | 0 | 1.82 |
| 2025-04 | 0 | 1.67 |
| 2025-05 | 0 | 1.63 |
| 2025-06 | 0 | 2.44 |
| 2025-07 | 0 | 1.86 |
| 2025-08 | 0 | 1.4 |
| 2025-09 | 2 | 2.86 |
| 2025-10 | 0 | 1.8 |
| 2025-11 | 0 | 2.25 |
| 2025-12 | 0 | 2.5 |
| 2026-01 | 0 | 2 |
| 2026-02 | 0 | 1.33 |
| 2026-03 | 0 | 3.67 |
| 2026-04 | 0 | 3.33 |
| 2026-05 | 0 | 2 |
| 2026-06 | 0 | 2 |
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 |
|---|---|---|---|---|
| 2025-09-17 | 3011706110-2025-00031 | Injury | Available | catalog number |
| 2025-02-14 | 3011706110-2025-00011 | Injury | Available | catalog number |
| 2024-06-30 | 3011706110-2024-00043 | Injury | Available | catalog number |
| 2024-06-21 | 3011706110-2024-00042 | Injury | Available | catalog number |
| 2024-03-08 | 3011706110-2024-00021 | Injury | Available | catalog number |
| 2024-01-04 | 3011706110-2024-00002 | Injury | Available | catalog number |
| 2023-11-10 | 3011706110-2023-00045 | Injury | Available | catalog number |
| 2023-09-21 | 3011706110-2023-00031 | Injury | Available | catalog number |
| 2023-07-07 | 3011706110-2023-00027 | Injury | Available | catalog number |
| 2022-09-07 | 3011706110-2022-00031 | Injury | Available | catalog number |
| 2022-05-20 | 3011706110-2022-00018 | Injury | Available | catalog number |
| 2022-05-06 | 3011706110-2022-00015 | Injury | Available | catalog number |
| 2022-05-06 | 3011706110-2022-00014 | Injury | Available | catalog number |
| 2021-04-28 | 3011706110-2021-00019 | Injury | Available | catalog number |
| 2020-11-20 | 3011706110-2020-00034 | Injury | Available | catalog number |
Showing the most recent 21 of 42 linked reports.
Showing 1–15 of 21
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2018-12-13 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2018-12-13 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2018-03-09 | VAI | Voluntary action indicated | AtriCure, Inc. | 0 |
| 2018-03-09 | VAI | Voluntary action indicated | AtriCure, Inc. | 3 |
| 2018-03-09 | VAI | Voluntary action indicated | AtriCure, Inc. | 3 |
| 2018-03-09 | VAI | Voluntary action indicated | AtriCure, Inc. | 0 |
| 2016-10-13 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2016-10-13 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2016-08-29 | VAI | Voluntary action indicated | AtriCure, Inc. | 3 |
| 2016-08-29 | VAI | Voluntary action indicated | AtriCure, Inc. | 3 |
| 2013-02-26 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2013-02-26 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2013-01-18 | VAI | Voluntary action indicated | AtriCure, Inc. | 1 |
| 2013-01-18 | VAI | Voluntary action indicated | AtriCure, Inc. | 1 |
| 2011-04-01 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2011-04-01 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2011-02-22 | VAI | Voluntary action indicated | AtriCure, Inc. | 0 |
| 2011-02-22 | VAI | Voluntary action indicated | AtriCure, Inc. | 0 |
| 2010-06-21 | NAI | No action indicated | AtriCure, Inc. | 0 |
| 2010-06-21 | NAI | No action indicated | AtriCure, Inc. | 0 |
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