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.
191 linked reportsInjury 176Malfunction 10Death 5
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-06 | 0 | 3 |
| 2019-07 | 0 | 4 |
| 2020-01 | 0 | 5 |
| 2020-05 | 0 | 2 |
| 2020-10 | 0 | 2 |
| 2021-07 | 0 | 1.5 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 5 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 2.5 |
| 2021-12 | 0 | 10 |
| 2022-01 | 0 | 5 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 2 |
| 2022-07 | 4 | 2.5 |
| 2022-08 | 3 | 3 |
| 2022-09 | 2 | 1.67 |
| 2022-10 | 5 | 2.67 |
| 2022-11 | 0 | 1 |
| 2022-12 | 2 | 2 |
| 2023-01 | 4 | 2.5 |
| 2023-02 | 3 | 3 |
| 2023-03 | 2 | 2 |
| 2023-04 | 8 | 8 |
| 2023-05 | 9 | 3.2 |
| 2023-06 | 2 | 1.5 |
| 2023-07 | 6 | 3 |
| 2023-08 | 4 | 4 |
| 2023-09 | 2 | 2 |
| 2023-10 | 6 | 6 |
| 2023-11 | 3 | 3 |
| 2023-12 | 2 | 2.5 |
| 2024-01 | 3 | 3 |
| 2024-02 | 2 | 2 |
| 2024-04 | 1 | 1 |
| 2024-05 | 1 | 1 |
| 2024-06 | 4 | 4 |
| 2024-09 | 3 | 3 |
| 2024-10 | 9 | 9 |
| 2024-11 | 0 | 1.5 |
| 2024-12 | 4 | 2.5 |
| 2025-01 | 3 | 3 |
| 2025-02 | 2 | 2 |
| 2025-03 | 2 | 1.5 |
| 2025-04 | 4 | 4 |
| 2025-05 | 2 | 1.67 |
| 2025-06 | 4 | 3 |
| 2025-07 | 15 | 7 |
| 2025-08 | 14 | 7.5 |
| 2025-09 | 9 | 5 |
| 2025-10 | 2 | 2 |
| 2025-11 | 3 | 3 |
| 2025-12 | 3 | 2 |
| 2026-01 | 9 | 6 |
| 2026-02 | 6 | 3 |
| 2026-03 | 3 | 3 |
| 2026-04 | 3 | 3 |
| 2026-05 | 5 | 4.5 |
| 2026-06 | 8 | 4.5 |
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 |
|---|---|---|---|---|
| 2026-06-10 | 1222780-2026-00375 | Injury | Available | catalog number |
| 2026-06-02 | 1222780-2026-00347 | Injury | Available | catalog number |
| 2026-06-02 | 1222780-2026-00346 | Injury | Available | catalog number |
| 2026-05-12 | 1222780-2026-00235 | Injury | Available | catalog number |
| 2026-05-12 | 1222780-2026-00238 | Injury | Available | catalog number |
| 2026-04-11 | 1222780-2026-00168 | Injury | Available | catalog number |
| 2026-03-04 | 1222780-2026-00099 | Injury | Available | catalog number |
| 2026-02-26 | 1222780-2026-00087 | Injury | Available | catalog number |
| 2026-02-16 | 1222780-2026-00065 | Injury | Available | catalog number |
| 2026-01-07 | 1222780-2026-00013 | Injury | Available | catalog number |
| 2026-01-06 | 1222780-2026-00008 | Injury | Available | catalog number |
| 2026-01-06 | 1222780-2026-00009 | Injury | Available | catalog number |
| 2025-12-30 | 1222780-2025-00656 | Injury | Available | catalog number |
| 2025-11-26 | 1222780-2025-00602 | Injury | Available | catalog number |
| 2025-10-31 | 1222780-2025-00559 | Injury | Available | catalog number |
Showing the most recent 95 of 191 linked reports.
Showing 1–15 of 95
Regulatory clearances
None linked.
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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