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.
92 linked reportsMalfunction 81Injury 10Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 10.5 |
| 2019-02 | 0 | 11.13 |
| 2019-03 | 0 | 8.57 |
| 2019-04 | 2 | 9.4 |
| 2019-05 | 0 | 8.47 |
| 2019-06 | 0 | 7.73 |
| 2019-07 | 1 | 8.03 |
| 2019-08 | 0 | 9.07 |
| 2019-09 | 2 | 12 |
| 2019-10 | 0 | 9.49 |
| 2019-11 | 0 | 8.85 |
| 2019-12 | 0 | 10.21 |
| 2020-01 | 1 | 9.41 |
| 2020-02 | 1 | 8.76 |
| 2020-03 | 1 | 8.97 |
| 2020-04 | 1 | 13.14 |
| 2020-05 | 0 | 9.03 |
| 2020-06 | 0 | 8.36 |
| 2020-07 | 0 | 8.15 |
| 2020-08 | 1 | 8.91 |
| 2020-09 | 0 | 10.35 |
| 2020-10 | 2 | 10.15 |
| 2020-11 | 0 | 11.16 |
| 2020-12 | 0 | 10.8 |
| 2021-01 | 1 | 10.02 |
| 2021-02 | 0 | 10.55 |
| 2021-03 | 0 | 14.58 |
| 2021-04 | 1 | 8.9 |
| 2021-05 | 4 | 7.47 |
| 2021-06 | 1 | 9.93 |
| 2021-07 | 0 | 8.43 |
| 2021-08 | 2 | 7.77 |
| 2021-09 | 0 | 7.44 |
| 2021-10 | 0 | 10.18 |
| 2021-11 | 0 | 10.54 |
| 2021-12 | 0 | 7.71 |
| 2022-01 | 0 | 7.26 |
| 2022-02 | 1 | 8.28 |
| 2022-03 | 0 | 11.32 |
| 2022-04 | 0 | 11.07 |
| 2022-05 | 5 | 15.27 |
| 2022-06 | 1 | 10.68 |
| 2022-07 | 0 | 7.27 |
| 2022-08 | 0 | 9.14 |
| 2022-09 | 0 | 12.08 |
| 2022-10 | 0 | 16.46 |
| 2022-11 | 0 | 9.11 |
| 2022-12 | 5 | 12.31 |
| 2023-01 | 0 | 10.07 |
| 2023-02 | 0 | 17.6 |
| 2023-03 | 0 | 19.41 |
| 2023-04 | 0 | 21.93 |
| 2023-05 | 0 | 21.78 |
| 2023-06 | 4 | 14.76 |
| 2023-07 | 2 | 27.83 |
| 2023-08 | 0 | 32.21 |
| 2023-09 | 0 | 32.73 |
| 2023-10 | 1 | 21.29 |
| 2023-11 | 0 | 31.3 |
| 2023-12 | 1 | 28.87 |
| 2024-01 | 3 | 26.92 |
| 2024-02 | 1 | 23.95 |
| 2024-03 | 0 | 30.02 |
| 2024-04 | 0 | 16.76 |
| 2024-05 | 27 | 18.2 |
| 2024-06 | 1 | 15.54 |
| 2024-07 | 0 | 26.88 |
| 2024-08 | 0 | 24.81 |
| 2024-09 | 1 | 30.13 |
| 2024-10 | 1 | 36.26 |
| 2024-11 | 1 | 26.81 |
| 2024-12 | 0 | 22.65 |
| 2025-01 | 1 | 28.25 |
| 2025-02 | 1 | 22 |
| 2025-03 | 0 | 27.79 |
| 2025-04 | 1 | 17.38 |
| 2025-05 | 2 | 14.64 |
| 2025-06 | 0 | 10.52 |
| 2025-07 | 1 | 10.23 |
| 2025-08 | 0 | 8.61 |
| 2025-09 | 0 | 9.3 |
| 2025-10 | 0 | 14.12 |
| 2025-11 | 0 | 8.46 |
| 2025-12 | 0 | 11.1 |
| 2026-01 | 0 | 11.34 |
| 2026-02 | 0 | 10.34 |
| 2026-03 | 1 | 11.79 |
| 2026-04 | 0 | 31.1 |
| 2026-05 | 4 | 15.68 |
| 2026-06 | 3 | 13.5 |
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 | 9610849-2026-00136 | Malfunction | — | exact di |
| 2026-06-20 | 9610849-2026-00134 | Malfunction | Available | exact di |
| 2026-06-09 | 9610849-2026-00127 | Malfunction | Available | exact di |
| 2026-05-29 | 9610849-2026-00120 | Malfunction | Available | exact di |
| 2026-05-29 | 9610849-2026-00119 | Malfunction | Available | exact di |
| 2026-05-04 | 9610849-2026-00100 | Malfunction | Available | exact di |
| 2026-05-04 | 9610849-2026-00101 | Malfunction | Available | exact di |
| 2026-03-20 | 9610849-2026-00073 | Malfunction | Available | exact di |
| 2025-07-24 | 9610849-2025-00015 | Malfunction | Available | exact di |
| 2025-05-05 | 1282497-2025-00291 | Malfunction | Available | exact di |
| 2025-05-04 | 1282497-2025-00289 | Malfunction | Available | exact di |
| 2025-04-04 | 1282497-2025-00215 | Malfunction | Available | exact di |
| 2025-02-06 | 1282497-2025-00060 | Malfunction | Available | exact di |
| 2025-01-22 | 2936999-2025-00031 | Malfunction | Available | exact di |
| 2024-11-11 | 1282497-2024-20004 | Malfunction | Available | exact di |
Showing 1–15 of 92
Regulatory clearances
Predicate lineage
K012891
Cited as predicate by: K123581, K130320, K150329, K162014, K180734, K181738, K190468, K192404, K201179, K211138, K212555, K250854, K253109
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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