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.
536 linked reportsMalfunction 524Injury 12
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.78 |
| 2019-02 | 4 | 2.69 |
| 2019-03 | 3 | 3.27 |
| 2019-04 | 12 | 4.36 |
| 2019-05 | 3 | 2.23 |
| 2019-06 | 10 | 4.77 |
| 2019-07 | 2 | 4.32 |
| 2019-08 | 5 | 3 |
| 2019-09 | 3 | 2.67 |
| 2019-10 | 2 | 3.18 |
| 2019-11 | 2 | 2.72 |
| 2019-12 | 2 | 3.65 |
| 2020-01 | 2 | 3 |
| 2020-02 | 0 | 3.67 |
| 2020-03 | 4 | 3.65 |
| 2020-04 | 0 | 3.17 |
| 2020-05 | 0 | 2.3 |
| 2020-06 | 0 | 5 |
| 2020-07 | 2 | 2.04 |
| 2020-08 | 0 | 2.5 |
| 2020-09 | 2 | 2.26 |
| 2020-10 | 0 | 3.5 |
| 2020-11 | 0 | 3.14 |
| 2020-12 | 2 | 4.21 |
| 2021-01 | 0 | 2.25 |
| 2021-02 | 10 | 4.5 |
| 2021-03 | 17 | 3.95 |
| 2021-04 | 6 | 3.53 |
| 2021-05 | 2 | 2.67 |
| 2021-06 | 38 | 7.33 |
| 2021-07 | 82 | 10.76 |
| 2021-08 | 29 | 5.43 |
| 2021-09 | 28 | 5.22 |
| 2021-10 | 30 | 7.62 |
| 2021-11 | 22 | 5.4 |
| 2021-12 | 42 | 6.65 |
| 2022-01 | 33 | 5.95 |
| 2022-02 | 9 | 3.39 |
| 2022-03 | 66 | 9.28 |
| 2022-04 | 2 | 4 |
| 2022-05 | 3 | 4.85 |
| 2022-06 | 0 | 2.05 |
| 2022-07 | 2 | 3.76 |
| 2022-08 | 2 | 3.21 |
| 2022-09 | 0 | 3.18 |
| 2022-10 | 0 | 2.91 |
| 2022-11 | 0 | 3.7 |
| 2022-12 | 0 | 10.85 |
| 2023-01 | 0 | 20.62 |
| 2023-02 | 4 | 8.76 |
| 2023-03 | 2 | 11.74 |
| 2023-04 | 0 | 12.83 |
| 2023-05 | 0 | 16.68 |
| 2023-06 | 0 | 17.52 |
| 2023-07 | 0 | 11.38 |
| 2023-08 | 0 | 10.61 |
| 2023-09 | 0 | 9.27 |
| 2023-10 | 0 | 10.57 |
| 2023-11 | 3 | 9.06 |
| 2023-12 | 0 | 10.81 |
| 2024-01 | 4 | 8.47 |
| 2024-02 | 2 | 11.07 |
| 2024-03 | 2 | 11.65 |
| 2024-04 | 4 | 9.86 |
| 2024-05 | 0 | 11.83 |
| 2024-06 | 2 | 9.03 |
| 2024-07 | 0 | 9.7 |
| 2024-08 | 2 | 10.74 |
| 2024-09 | 0 | 12 |
| 2024-10 | 0 | 10.05 |
| 2024-11 | 2 | 7.97 |
| 2024-12 | 0 | 11.71 |
| 2025-01 | 0 | 9.85 |
| 2025-02 | 4 | 12.36 |
| 2025-03 | 3 | 9.44 |
| 2025-04 | 0 | 10.03 |
| 2025-05 | 2 | 9.39 |
| 2025-06 | 0 | 8.24 |
| 2025-07 | 7 | 9.1 |
| 2025-08 | 0 | 9.82 |
| 2025-09 | 0 | 8.97 |
| 2025-10 | 7 | 8 |
| 2025-11 | 0 | 9.32 |
| 2025-12 | 0 | 9.75 |
| 2026-01 | 0 | 11.85 |
| 2026-02 | 0 | 16.95 |
| 2026-03 | 3 | 7.96 |
| 2026-04 | 0 | 8.59 |
| 2026-05 | 0 | 5.76 |
| 2026-06 | 0 | 7.7 |
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 |
|---|---|---|---|---|
| 2026-03-20 | 1222780-2026-00132 | Injury | Available | catalog number |
| 2025-10-27 | 23390191 | Malfunction | Available | catalog number |
| 2025-10-27 | 23389744 | Malfunction | Available | catalog number |
| 2025-10-01 | 23187760 | Malfunction | Available | catalog number |
| 2025-07-18 | 22540940 | Malfunction | Available | catalog number |
| 2025-07-18 | 22541084 | Malfunction | Available | catalog number |
| 2025-07-17 | 22530078 | Malfunction | Available | catalog number |
| 2025-05-12 | 22001884 | Malfunction | Available | catalog number |
| 2025-03-05 | 21525206 | Malfunction | Available | catalog number |
| 2025-02-28 | 1222780-2025-00104 | Injury | Available | catalog number |
| 2025-02-04 | 21303344 | Malfunction | Available | catalog number |
| 2024-11-19 | 20722742 | Malfunction | Available | catalog number |
| 2024-08-01 | 19881980 | Malfunction | Available | catalog number |
| 2024-06-26 | 19613800 | Malfunction | Available | catalog number |
| 2024-04-30 | 1222780-2024-00168 | Injury | Available | catalog number |
Showing the most recent 200 of 536 linked reports.
Showing 1–15 of 200
Regulatory clearances
- 510(k)K180825Substantially equivalent (SESE) · 2018-08-03clearance family
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 |
|---|---|---|---|---|
| 2025-11-04 | 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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