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.
572 linked reportsInjury 350Malfunction 222
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 3 | 11.13 |
| 2019-02 | 12 | 4.13 |
| 2019-03 | 0 | 2.6 |
| 2019-04 | 0 | 3.54 |
| 2019-05 | 0 | 7.38 |
| 2019-06 | 0 | 41.85 |
| 2019-07 | 0 | 9.24 |
| 2019-08 | 1 | 63.43 |
| 2019-09 | 1 | 30.31 |
| 2019-10 | 3 | 11.12 |
| 2019-11 | 3 | 33.61 |
| 2019-12 | 0 | 46.68 |
| 2020-01 | 5 | 42.17 |
| 2020-02 | 0 | 34.08 |
| 2020-03 | 0 | 137.06 |
| 2020-04 | 0 | 64.38 |
| 2020-05 | 1 | 33.55 |
| 2020-06 | 4 | 66.13 |
| 2020-07 | 4 | 57.25 |
| 2020-08 | 0 | 33.63 |
| 2020-09 | 0 | 40.24 |
| 2020-10 | 4 | 22.5 |
| 2020-11 | 0 | 28.13 |
| 2020-12 | 0 | 15.74 |
| 2021-01 | 0 | 20.28 |
| 2021-02 | 0 | 12.97 |
| 2021-03 | 5 | 12.7 |
| 2021-04 | 0 | 9.2 |
| 2021-05 | 3 | 4.29 |
| 2021-06 | 0 | 4.73 |
| 2021-07 | 3 | 5.88 |
| 2021-08 | 0 | 6.48 |
| 2021-09 | 0 | 10.65 |
| 2021-10 | 10 | 5.43 |
| 2021-11 | 8 | 4.23 |
| 2021-12 | 0 | 7.62 |
| 2022-01 | 20 | 6.9 |
| 2022-02 | 11 | 8.39 |
| 2022-03 | 2 | 5.7 |
| 2022-04 | 4 | 3.76 |
| 2022-05 | 3 | 3 |
| 2022-06 | 3 | 2.68 |
| 2022-07 | 12 | 3.74 |
| 2022-08 | 7 | 3.95 |
| 2022-09 | 18 | 5.42 |
| 2022-10 | 19 | 5.95 |
| 2022-11 | 2 | 3.96 |
| 2022-12 | 0 | 5.74 |
| 2023-01 | 0 | 3.73 |
| 2023-02 | 3 | 6.29 |
| 2023-03 | 0 | 5.15 |
| 2023-04 | 14 | 6.26 |
| 2023-05 | 9 | 5.15 |
| 2023-06 | 3 | 5.86 |
| 2023-07 | 0 | 4.95 |
| 2023-08 | 6 | 5.79 |
| 2023-09 | 4 | 4.77 |
| 2023-10 | 14 | 8.78 |
| 2023-11 | 0 | 7.22 |
| 2023-12 | 6 | 7.63 |
| 2024-01 | 2 | 9.97 |
| 2024-02 | 6 | 5.16 |
| 2024-03 | 0 | 4.15 |
| 2024-04 | 20 | 7.54 |
| 2024-05 | 3 | 5.44 |
| 2024-06 | 0 | 11.85 |
| 2024-07 | 0 | 6.11 |
| 2024-08 | 5 | 10.25 |
| 2024-09 | 15 | 13.25 |
| 2024-10 | 4 | 6.5 |
| 2024-11 | 11 | 4.24 |
| 2024-12 | 0 | 5.88 |
| 2025-01 | 0 | 4.57 |
| 2025-02 | 12 | 6.66 |
| 2025-03 | 4 | 11.29 |
| 2025-04 | 0 | 8.63 |
| 2025-05 | 0 | 8.45 |
| 2025-06 | 0 | 6.93 |
| 2025-07 | 4 | 6.06 |
| 2025-08 | 28 | 12.38 |
| 2025-09 | 7 | 6.9 |
| 2025-10 | 13 | 5.83 |
| 2025-11 | 4 | 8.5 |
| 2025-12 | 13 | 9.26 |
| 2026-01 | 20 | 15.75 |
| 2026-02 | 24 | 16.68 |
| 2026-03 | 32 | 11.69 |
| 2026-04 | 32 | 15.03 |
| 2026-05 | 16 | 15.8 |
| 2026-06 | 67 | 23.48 |
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 |
|---|---|---|---|---|
| 2026-06-30 | 1222780-2026-00414 | Malfunction | — | catalog number |
| 2026-06-29 | 1222780-2026-00410 | Injury | Available | catalog number |
| 2026-06-26 | 1222780-2026-00409 | Malfunction | — | catalog number |
| 2026-06-17 | 1222780-2026-00392 | Injury | Available | catalog number |
| 2026-06-15 | 1222780-2026-00382 | Malfunction | Available | catalog number |
| 2026-06-09 | 1222780-2026-00357 | Injury | Available | catalog number |
| 2026-06-09 | 1222780-2026-00356 | Malfunction | Available | catalog number |
| 2026-06-04 | 1222780-2026-00349 | Injury | Available | catalog number |
| 2026-06-03 | 25374076 | Malfunction | Available | catalog number |
| 2026-06-03 | 1222780-2026-00348 | Injury | Available | catalog number |
| 2026-06-02 | 1222780-2026-00344 | Injury | Available | catalog number |
| 2026-06-02 | 1222780-2026-00345 | Injury | Available | catalog number |
| 2026-06-01 | 25347496 | Malfunction | Available | catalog number |
| 2026-06-01 | 1222780-2026-00337 | Injury | Available | catalog number |
| 2026-06-01 | 25347559 | Malfunction | Available | catalog number |
Showing the most recent 170 of 572 linked reports.
Showing 1–15 of 170
Regulatory clearances
- 510(k)K180233Substantially equivalent (SESE) · 2018-04-10clearance family
Predicate lineage
- K180233
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 |
|---|---|---|---|---|
| 2025-11-04 | 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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