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.
163 linked reportsMalfunction 159Injury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.42 |
| 2019-02 | 4 | 3.53 |
| 2019-03 | 0 | 2.95 |
| 2019-04 | 1 | 3.13 |
| 2019-05 | 1 | 2.46 |
| 2019-06 | 4 | 3.58 |
| 2019-07 | 0 | 2.42 |
| 2019-08 | 0 | 2.47 |
| 2019-09 | 3 | 2.47 |
| 2019-10 | 1 | 2.71 |
| 2019-11 | 2 | 2.12 |
| 2019-12 | 5 | 2.35 |
| 2020-01 | 2 | 2.55 |
| 2020-02 | 8 | 2.7 |
| 2020-03 | 1 | 2.28 |
| 2020-04 | 1 | 2.54 |
| 2020-05 | 0 | 1.98 |
| 2020-06 | 1 | 2.78 |
| 2020-07 | 1 | 2.77 |
| 2020-08 | 1 | 4.33 |
| 2020-09 | 1 | 4.4 |
| 2020-10 | 5 | 3.99 |
| 2020-11 | 2 | 4.47 |
| 2020-12 | 1 | 3.87 |
| 2021-01 | 0 | 3.99 |
| 2021-02 | 0 | 3.89 |
| 2021-03 | 3 | 4.83 |
| 2021-04 | 1 | 4.7 |
| 2021-05 | 2 | 4.05 |
| 2021-06 | 2 | 4.28 |
| 2021-07 | 3 | 3.88 |
| 2021-08 | 1 | 3.87 |
| 2021-09 | 0 | 3.91 |
| 2021-10 | 1 | 3.99 |
| 2021-11 | 1 | 3.49 |
| 2021-12 | 1 | 4.46 |
| 2022-01 | 2 | 4.57 |
| 2022-02 | 1 | 5.03 |
| 2022-03 | 2 | 5.45 |
| 2022-04 | 1 | 6.48 |
| 2022-05 | 1 | 5.46 |
| 2022-06 | 0 | 6.07 |
| 2022-07 | 0 | 6.34 |
| 2022-08 | 2 | 6.38 |
| 2022-09 | 0 | 5.53 |
| 2022-10 | 1 | 5.35 |
| 2022-11 | 2 | 5.52 |
| 2022-12 | 3 | 6 |
| 2023-01 | 2 | 5.73 |
| 2023-02 | 2 | 4.87 |
| 2023-03 | 1 | 5.86 |
| 2023-04 | 0 | 5.47 |
| 2023-05 | 2 | 5.86 |
| 2023-06 | 0 | 7.1 |
| 2023-07 | 0 | 6.1 |
| 2023-08 | 0 | 6.28 |
| 2023-09 | 0 | 5.92 |
| 2023-10 | 4 | 6.38 |
| 2023-11 | 2 | 5.76 |
| 2023-12 | 2 | 6.05 |
| 2024-01 | 15 | 5.53 |
| 2024-02 | 3 | 6.18 |
| 2024-03 | 1 | 5.56 |
| 2024-04 | 2 | 6.32 |
| 2024-05 | 0 | 5.3 |
| 2024-06 | 0 | 7.07 |
| 2024-07 | 1 | 5.75 |
| 2024-08 | 3 | 6.5 |
| 2024-09 | 0 | 6.28 |
| 2024-10 | 0 | 7.11 |
| 2024-11 | 4 | 4.55 |
| 2024-12 | 0 | 4.77 |
| 2025-01 | 4 | 4.42 |
| 2025-02 | 0 | 4.03 |
| 2025-03 | 1 | 5.17 |
| 2025-04 | 8 | 4.67 |
| 2025-05 | 0 | 4.69 |
| 2025-06 | 8 | 4.58 |
| 2025-07 | 3 | 4.68 |
| 2025-08 | 2 | 5.45 |
| 2025-09 | 0 | 3.97 |
| 2025-10 | 2 | 4.59 |
| 2025-11 | 2 | 4.86 |
| 2025-12 | 0 | 6.15 |
| 2026-01 | 5 | 4.95 |
| 2026-02 | 1 | 5.05 |
| 2026-03 | 0 | 5.77 |
| 2026-04 | 4 | 6.2 |
| 2026-05 | 0 | 5.86 |
| 2026-06 | 4 | 5.01 |
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 |
|---|---|---|---|---|
| 2026-06-11 | 25470436 | Malfunction | Available | model number |
| 2026-06-08 | 25428753 | Malfunction | Available | model number |
| 2026-04-09 | 24829132 | Malfunction | Available | model number |
| 2026-04-09 | 24829131 | Malfunction | Available | model number |
| 2026-02-02 | 9612501-2026-00232 | Malfunction | Available | exact di |
| 2026-01-22 | 24150114 | Malfunction | Available | exact di |
| 2026-01-15 | 24078625 | Malfunction | Available | model number |
| 2025-11-07 | 23496028 | Malfunction | Available | model number |
| 2025-10-29 | 23412930 | Malfunction | Available | model number |
| 2025-08-25 | 22886525 | Malfunction | Available | model number |
| 2025-07-17 | 22529804 | Malfunction | Available | exact di |
| 2025-06-24 | 22318620 | Malfunction | Available | exact di |
| 2025-06-05 | 9612501-2025-01448 | Malfunction | Available | exact di |
| 2025-06-02 | 22122405 | Malfunction | Available | model number |
| 2025-06-02 | 22122610 | Malfunction | Available | model number |
Showing the most recent 124 of 163 linked reports.
Showing 1–15 of 124
Regulatory clearances
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 |
|---|---|---|---|---|
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2025-07-16 | NAI | No action indicated | Covidien LLC | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2024-11-21 | NAI | No action indicated | Covidien, LP | 0 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-11-18 | VAI | Voluntary action indicated | Covidien LP | 1 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-09-08 | VAI | Voluntary action indicated | Covidien | 0 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2022-04-28 | OAI | Official action indicated | Covidien | 2 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2020-02-28 | VAI | Voluntary action indicated | Covidien, LP | 1 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2018-09-19 | NAI | No action indicated | Covidien | 0 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-09-22 | VAI | Voluntary action indicated | Covidien, LLC | 2 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2017-08-09 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2016-10-31 | NAI | No action indicated | Covidien | 0 |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2012-06-14 | WL | Warning Letter | Covidien, LP | — |
| 2011-10-04 | WL | Warning Letter | Oridion Medical 1987 Ltd. | — |
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