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.
10 linked reportsMalfunction 10
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-02 | 0 | 2 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 3 |
| 2019-06 | 0 | 2 |
| 2019-07 | 0 | 2 |
| 2019-08 | 0 | 2 |
| 2019-09 | 0 | 2 |
| 2019-11 | 0 | 3 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 2.67 |
| 2020-03 | 0 | 2 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 2 |
| 2020-08 | 0 | 2 |
| 2020-09 | 0 | 2 |
| 2020-12 | 0 | 2 |
| 2021-02 | 0 | 2 |
| 2021-05 | 0 | 2 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 4 |
| 2021-11 | 0 | 4 |
| 2021-12 | 0 | 2 |
| 2022-02 | 0 | 2 |
| 2022-03 | 0 | 4.33 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 1.5 |
| 2022-06 | 0 | 3 |
| 2022-08 | 0 | 6 |
| 2022-09 | 0 | 3 |
| 2022-10 | 0 | 2.5 |
| 2022-11 | 0 | 3.5 |
| 2022-12 | 0 | 3 |
| 2023-01 | 0 | 3 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 3.33 |
| 2023-04 | 0 | 2 |
| 2023-06 | 0 | 2 |
| 2023-08 | 0 | 1.5 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 5 |
| 2023-12 | 0 | 4 |
| 2024-01 | 1 | 1.5 |
| 2024-02 | 0 | 7 |
| 2024-03 | 0 | 5.5 |
| 2024-04 | 3 | 3.5 |
| 2024-05 | 0 | 5 |
| 2024-06 | 0 | 5.5 |
| 2024-07 | 0 | 5.67 |
| 2024-08 | 0 | 6.33 |
| 2024-09 | 0 | 4.5 |
| 2024-10 | 0 | 2.5 |
| 2024-11 | 0 | 6.25 |
| 2024-12 | 0 | 4 |
| 2025-01 | 0 | 2 |
| 2025-02 | 1 | 3 |
| 2025-03 | 0 | 4 |
| 2025-04 | 0 | 7.75 |
| 2025-05 | 0 | 16 |
| 2025-06 | 0 | 4.2 |
| 2025-07 | 0 | 10 |
| 2025-08 | 3 | 3.33 |
| 2025-09 | 0 | 6.33 |
| 2025-10 | 0 | 3.75 |
| 2025-11 | 0 | 3.75 |
| 2025-12 | 0 | 4.25 |
| 2026-01 | 0 | 4 |
| 2026-02 | 0 | 7.33 |
| 2026-03 | 0 | 7 |
| 2026-04 | 0 | 6.5 |
| 2026-05 | 2 | 5.29 |
| 2026-06 | 0 | 8.75 |
Failure-mode summaryAI-generated
10 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2026-04-08 | Z-2168-2026 | Class II | Open, Classified | Complaints have been received of systems developing loose, missing, or broken internal bolts over time.Distribution: US Nationwide distribution. | 14837 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-21 | 3005496266-2026-00113 | Malfunction | Available | catalog number |
| 2025-08-07 | 3005496266-2025-00044 | Malfunction | Available | catalog number |
| 2025-02-04 | 1220984-2025-00008 | Malfunction | Available | exact di |
| 2024-04-29 | 1220984-2024-00040 | Malfunction | Available | catalog number |
| 2024-01-10 | 1220984-2024-00001 | Malfunction | Available | exact di |
Showing the most recent 5 of 10 linked reports.
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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