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.
106 linked reportsInjury 99Malfunction 7
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.21 |
| 2019-02 | 0 | 1.67 |
| 2019-03 | 0 | 1.75 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.33 |
| 2019-07 | 0 | 1.75 |
| 2019-08 | 0 | 2.82 |
| 2019-09 | 0 | 2 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 1.83 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 1.6 |
| 2020-02 | 0 | 1.67 |
| 2020-03 | 0 | 3 |
| 2020-04 | 0 | 1.83 |
| 2020-05 | 0 | 3 |
| 2020-06 | 0 | 4 |
| 2020-07 | 0 | 2 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1.5 |
| 2020-11 | 0 | 1.6 |
| 2020-12 | 0 | 1.75 |
| 2021-01 | 0 | 1 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 1.5 |
| 2021-04 | 0 | 2.71 |
| 2021-05 | 0 | 2.22 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 4.5 |
| 2021-08 | 0 | 1.6 |
| 2021-09 | 0 | 7.5 |
| 2021-10 | 0 | 1.44 |
| 2021-11 | 1 | 2.2 |
| 2021-12 | 0 | 2.43 |
| 2022-01 | 0 | 6.83 |
| 2022-02 | 0 | 2.14 |
| 2022-03 | 1 | 1.38 |
| 2022-04 | 0 | 2.27 |
| 2022-05 | 2 | 1.24 |
| 2022-06 | 2 | 2.2 |
| 2022-07 | 2 | 3 |
| 2022-08 | 0 | 1.8 |
| 2022-09 | 0 | 2.6 |
| 2022-10 | 0 | 1.86 |
| 2022-11 | 0 | 1.3 |
| 2022-12 | 0 | 1.5 |
| 2023-01 | 0 | 1.4 |
| 2023-02 | 0 | 2.27 |
| 2023-03 | 0 | 1.91 |
| 2023-04 | 0 | 1.67 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 6.67 |
| 2023-07 | 0 | 3.5 |
| 2023-08 | 0 | 1.14 |
| 2023-09 | 11 | 7.61 |
| 2023-10 | 6 | 3.63 |
| 2023-11 | 0 | 3.57 |
| 2023-12 | 2 | 2.4 |
| 2024-01 | 0 | 2 |
| 2024-02 | 0 | 2 |
| 2024-03 | 0 | 2.73 |
| 2024-04 | 2 | 3.53 |
| 2024-05 | 0 | 2.89 |
| 2024-06 | 0 | 1.82 |
| 2024-07 | 0 | 2.22 |
| 2024-08 | 2 | 7.25 |
| 2024-09 | 0 | 3.17 |
| 2024-10 | 12 | 7.86 |
| 2024-11 | 3 | 2.93 |
| 2024-12 | 0 | 3.07 |
| 2025-01 | 3 | 3.94 |
| 2025-02 | 3 | 3.78 |
| 2025-03 | 18 | 19.52 |
| 2025-04 | 3 | 11.18 |
| 2025-05 | 0 | 3.75 |
| 2025-06 | 6 | 5 |
| 2025-07 | 3 | 3.73 |
| 2025-08 | 3 | 5.5 |
| 2025-09 | 0 | 2.67 |
| 2025-10 | 0 | 1.62 |
| 2025-11 | 0 | 1.5 |
| 2025-12 | 3 | 2.89 |
| 2026-01 | 0 | 2.64 |
| 2026-02 | 0 | 2.1 |
| 2026-03 | 0 | 5.71 |
| 2026-04 | 0 | 2.38 |
| 2026-05 | 18 | 10.04 |
| 2026-06 | 0 | 2.2 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-10-10 | Z-0328-2025 | Class I | Open, Classified | Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.Distribution: Domestic: US Nationwide Distribution. | 12,710 units | code info di |
| 2024-03-13 | Z-1733-2024 | Class I | Open, Classified | Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the deviceDistribution: US Nationwide Distribution | 53492 | code info di |
| 2022-08-09 | Z-1858-2022 | Class II | Open, Classified | Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.Distribution: US Nationwide distribution including in the states of FL, IL, MD, NJ, AZ, TX, WA, VA, OK, NC, NH, GA, CA, CT, OH, CO, MI, MO, KS, TN, ID, MS, MT, AL, OR, IA, PA, MA. | 233 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-25 | 1222780-2026-00324 | Injury | Available | catalog number |
| 2026-05-18 | 1222780-2026-00286 | Injury | Available | catalog number |
| 2026-05-18 | 1222780-2026-00285 | Injury | Available | catalog number |
| 2026-05-13 | 1222780-2026-00276 | Injury | Available | catalog number |
| 2026-05-12 | 1222780-2026-00258 | Injury | Available | catalog number |
| 2026-05-12 | 1222780-2026-00250 | Injury | Available | catalog number |
| 2026-05-10 | 1222780-2026-00210 | Injury | Available | catalog number |
| 2025-12-10 | 1222780-2025-00627 | Injury | Available | catalog number |
| 2025-08-06 | 1222780-2025-00433 | Injury | Available | catalog number |
| 2025-07-17 | 1222780-2025-00389 | Injury | Available | catalog number |
| 2025-06-30 | 1222780-2025-00357 | Injury | Available | catalog number |
| 2025-06-30 | MW5172117 | Malfunction | Available | model number |
| 2025-06-25 | 1222780-2025-00338 | Injury | Available | catalog number |
| 2025-04-15 | 1222780-2025-00186 | Injury | Available | catalog number |
| 2025-03-24 | 1222780-2025-01143 | Injury | Available | catalog number |
Showing the most recent 41 of 106 linked reports.
Showing 1–15 of 41
Regulatory clearances
- 510(k)K152070Substantially equivalent (SESE) · 2015-08-26clearance 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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