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.
84 linked reportsInjury 49Malfunction 35
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 2.29 |
| 2019-02 | 2 | 3 |
| 2019-03 | 1 | 4.43 |
| 2019-04 | 1 | 3.67 |
| 2019-05 | 4 | 5.83 |
| 2019-06 | 0 | 1.75 |
| 2019-07 | 1 | 4.17 |
| 2019-08 | 0 | 5 |
| 2019-09 | 2 | 2.57 |
| 2019-10 | 4 | 4.22 |
| 2019-11 | 0 | 4.25 |
| 2019-12 | 1 | 2.5 |
| 2020-01 | 5 | 2.78 |
| 2020-02 | 2 | 3.2 |
| 2020-03 | 2 | 2.43 |
| 2020-04 | 0 | 2.17 |
| 2020-05 | 2 | 3.33 |
| 2020-06 | 1 | 2.5 |
| 2020-07 | 0 | 2.71 |
| 2020-08 | 0 | 3.5 |
| 2020-09 | 2 | 4.86 |
| 2020-10 | 0 | 2.83 |
| 2020-11 | 5 | 3.6 |
| 2020-12 | 8 | 8 |
| 2021-01 | 1 | 2.67 |
| 2021-02 | 0 | 4 |
| 2021-03 | 4 | 8.2 |
| 2021-04 | 2 | 6.5 |
| 2021-05 | 2 | 7.8 |
| 2021-06 | 0 | 8 |
| 2021-07 | 3 | 4.83 |
| 2021-08 | 0 | 8.67 |
| 2021-09 | 4 | 3.71 |
| 2021-10 | 1 | 4 |
| 2021-11 | 5 | 13 |
| 2021-12 | 0 | 13.75 |
| 2022-01 | 0 | 4.33 |
| 2022-02 | 1 | 2.17 |
| 2022-03 | 7 | 5.83 |
| 2022-04 | 0 | 2.25 |
| 2022-05 | 4 | 2.5 |
| 2022-06 | 0 | 3.43 |
| 2022-07 | 0 | 5.5 |
| 2022-08 | 0 | 7.75 |
| 2022-09 | 0 | 3.4 |
| 2022-10 | 2 | 5.43 |
| 2022-11 | 0 | 4.63 |
| 2022-12 | 0 | 11.2 |
| 2023-01 | 0 | 5.83 |
| 2023-02 | 0 | 3.71 |
| 2023-03 | 0 | 5.57 |
| 2023-04 | 0 | 7.2 |
| 2023-05 | 0 | 5.6 |
| 2023-06 | 0 | 6.17 |
| 2023-07 | 0 | 5.75 |
| 2023-08 | 0 | 6 |
| 2023-09 | 0 | 3.22 |
| 2023-10 | 2 | 4 |
| 2023-11 | 0 | 5.44 |
| 2023-12 | 0 | 7 |
| 2024-01 | 1 | 4.22 |
| 2024-02 | 0 | 12.75 |
| 2024-03 | 0 | 6.17 |
| 2024-04 | 0 | 3.8 |
| 2024-05 | 0 | 10.5 |
| 2024-06 | 0 | 3.71 |
| 2024-07 | 0 | 2.75 |
| 2024-08 | 0 | 2.33 |
| 2024-09 | 0 | 5.67 |
| 2024-10 | 0 | 3.8 |
| 2024-11 | 0 | 5.5 |
| 2024-12 | 0 | 3 |
| 2025-01 | 0 | 4.56 |
| 2025-02 | 0 | 4.67 |
| 2025-03 | 0 | 6.33 |
| 2025-04 | 0 | 5.14 |
| 2025-05 | 0 | 7.25 |
| 2025-06 | 0 | 6.14 |
| 2025-07 | 0 | 3 |
| 2025-08 | 0 | 9 |
| 2025-09 | 0 | 4.17 |
| 2025-10 | 0 | 4 |
| 2025-11 | 0 | 3 |
| 2025-12 | 0 | 5.33 |
| 2026-01 | 0 | 5.5 |
| 2026-02 | 0 | 4.4 |
| 2026-03 | 0 | 11 |
| 2026-04 | 0 | 4.5 |
| 2026-05 | 0 | 2.33 |
| 2026-06 | 0 | 8.5 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2014-01-24 | Z-1094-2014 | Class II | Terminated | NovaSure Radiofrequency Control Units may not meet a requirement of the electrical standard, IEC 60601-1,Distribution: Worldwide Distribution - USA Nationwide and the countries Canada, France, Germany, and Sweden | 93 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-01-08 | 1222780-2024-00010 | Injury | Available | exact di |
| 2023-10-31 | 1222780-2023-00410 | Injury | Available | catalog number |
| 2022-10-11 | 1222780-2022-00284 | Malfunction | Available | catalog number |
| 2022-05-12 | 1222780-2022-00129 | Injury | Available | catalog number |
| 2022-05-09 | 1222780-2022-00125 | Malfunction | Available | catalog number |
| 2022-03-30 | 13948687 | Malfunction | Available | catalog number |
| 2022-03-15 | 1222780-2022-00092 | Injury | Available | exact di |
| 2022-03-15 | 1222780-2022-00086 | Injury | Available | exact di |
| 2022-03-15 | 1222780-2022-00094 | Injury | Available | exact di |
| 2022-03-15 | 1222780-2022-00084 | Injury | Available | exact di |
| 2022-03-15 | 1222780-2022-00085 | Injury | Available | exact di |
| 2022-03-15 | 1222780-2022-00093 | Injury | Available | exact di |
| 2022-02-16 | 1222780-2022-00043 | Injury | Available | catalog number |
| 2021-11-23 | 1222780-2021-00338 | Injury | Available | catalog number |
| 2021-11-23 | 1222780-2021-00337 | Injury | Available | catalog number |
Showing the most recent 61 of 84 linked reports.
Showing 1–15 of 61
Regulatory clearances
- PMAP01001330-day notice accepted (OK30) · 2025-12-17 · +19 earlier decisionsclearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2025-11-04 | OAI | Official action indicated | Hologic, Inc | 3 |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-12-18 | WL | Warning Letter | Hologic, Inc | — |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-24 | OAI | Official action indicated | Hologic, Inc | 5 |
| 2024-09-12 | VAI | Voluntary action indicated | Hologic Surgical Products Costa Rica, S.R.L. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2024-08-13 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2022-12-14 | NAI | No action indicated | Bolder Surgical, LLC | 0 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-10-14 | OAI | Official action indicated | Hologic, Inc. | 4 |
| 2022-08-03 | VAI | Voluntary action indicated | Health Beacons, Inc. | 1 |
| 2020-02-25 | NAI | No action indicated | Health Beacons, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-12-10 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2018-02-27 | NAI | No action indicated | Gynesonics, Inc. | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-30 | NAI | No action indicated | Hologic, Inc | 0 |
| 2017-11-27 | VAI | Voluntary action indicated | Bolder Surgical, LLC | 6 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
| 2017-10-25 | NAI | No action indicated | Hologic, Inc. | 0 |
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