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.
29 linked reportsMalfunction 27Death 1Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.61 |
| 2019-02 | 0 | 1.91 |
| 2019-03 | 0 | 1.82 |
| 2019-04 | 0 | 2.36 |
| 2019-05 | 0 | 1.75 |
| 2019-06 | 0 | 1.88 |
| 2019-07 | 0 | 2.51 |
| 2019-08 | 0 | 1.98 |
| 2019-09 | 0 | 1.7 |
| 2019-10 | 0 | 2.7 |
| 2019-11 | 0 | 1.95 |
| 2019-12 | 0 | 2.02 |
| 2020-01 | 0 | 2.84 |
| 2020-02 | 0 | 2.03 |
| 2020-03 | 0 | 2.19 |
| 2020-04 | 0 | 2.62 |
| 2020-05 | 0 | 2 |
| 2020-06 | 0 | 2.3 |
| 2020-07 | 0 | 3.16 |
| 2020-08 | 2 | 2.25 |
| 2020-09 | 0 | 2.27 |
| 2020-10 | 0 | 3.12 |
| 2020-11 | 2 | 2.26 |
| 2020-12 | 2 | 2.59 |
| 2021-01 | 0 | 2.54 |
| 2021-02 | 2 | 2.54 |
| 2021-03 | 0 | 2.38 |
| 2021-04 | 6 | 2.24 |
| 2021-05 | 3 | 2.74 |
| 2021-06 | 2 | 2.46 |
| 2021-07 | 2 | 2.21 |
| 2021-08 | 0 | 2.49 |
| 2021-09 | 2 | 2.25 |
| 2021-10 | 2 | 2.36 |
| 2021-11 | 0 | 2.08 |
| 2021-12 | 0 | 2.26 |
| 2022-01 | 0 | 2.18 |
| 2022-02 | 0 | 2.17 |
| 2022-03 | 0 | 1.97 |
| 2022-04 | 0 | 2.25 |
| 2022-05 | 1 | 1.86 |
| 2022-06 | 0 | 2.22 |
| 2022-07 | 0 | 2.06 |
| 2022-08 | 0 | 2.37 |
| 2022-09 | 0 | 2.18 |
| 2022-10 | 0 | 2.2 |
| 2022-11 | 0 | 2.06 |
| 2022-12 | 1 | 1.92 |
| 2023-01 | 0 | 1.8 |
| 2023-02 | 0 | 1.96 |
| 2023-03 | 0 | 2.01 |
| 2023-04 | 0 | 2.13 |
| 2023-05 | 0 | 1.85 |
| 2023-06 | 0 | 2.11 |
| 2023-07 | 0 | 2.05 |
| 2023-08 | 0 | 1.85 |
| 2023-09 | 0 | 1.92 |
| 2023-10 | 0 | 2.21 |
| 2023-11 | 0 | 2.39 |
| 2023-12 | 0 | 2.42 |
| 2024-01 | 0 | 1.77 |
| 2024-02 | 1 | 1.96 |
| 2024-03 | 0 | 1.83 |
| 2024-04 | 0 | 1.92 |
| 2024-05 | 0 | 1.94 |
| 2024-06 | 0 | 2.12 |
| 2024-07 | 0 | 1.99 |
| 2024-08 | 0 | 1.97 |
| 2024-09 | 0 | 2.07 |
| 2024-10 | 0 | 2.28 |
| 2024-11 | 0 | 2.41 |
| 2024-12 | 0 | 2.97 |
| 2025-01 | 0 | 2.91 |
| 2025-02 | 0 | 2.87 |
| 2025-03 | 0 | 2.68 |
| 2025-04 | 1 | 2.49 |
| 2025-05 | 0 | 2.66 |
| 2025-06 | 0 | 3.23 |
| 2025-07 | 0 | 3.2 |
| 2025-08 | 0 | 2.73 |
| 2025-09 | 0 | 2.88 |
| 2025-10 | 0 | 3.24 |
| 2025-11 | 0 | 3.19 |
| 2025-12 | 0 | 3.84 |
| 2026-01 | 0 | 3.49 |
| 2026-02 | 0 | 3.34 |
| 2026-03 | 0 | 3.29 |
| 2026-04 | 0 | 3.06 |
| 2026-05 | 0 | 3.41 |
| 2026-06 | 0 | 3.38 |
Failure-mode summaryAI-generated
29 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-04-18 | 3005168196-2025-00126 | Death | Available | exact di |
| 2024-02-05 | 3005168196-2024-00039 | Malfunction | Available | exact di |
| 2022-12-09 | 3005168196-2022-00572 | Malfunction | Available | exact di |
| 2022-05-27 | 3005168196-2022-00241 | Injury | Available | exact di |
| 2021-10-18 | 3005168196-2021-02287 | Malfunction | Available | exact di |
| 2021-09-14 | 3005168196-2021-02033 | Malfunction | Available | exact di |
| 2021-07-07 | 3005168196-2021-01482 | Malfunction | Available | exact di |
| 2021-06-03 | 3005168196-2021-01237 | Malfunction | Available | exact di |
| 2021-05-18 | MW5101407 | Malfunction | Available | exact di |
| 2021-05-08 | 3005168196-2021-00987 | Malfunction | Available | exact di |
| 2021-04-25 | 3005168196-2021-00857 | Malfunction | Available | exact di |
| 2021-04-20 | 3005168196-2021-00801 | Malfunction | Available | exact di |
| 2021-04-12 | 3005168196-2021-00723 | Malfunction | Available | exact di |
| 2021-02-12 | 3005168196-2021-00269 | Malfunction | Available | exact di |
| 2020-12-09 | 3005168196-2020-02230 | Malfunction | Available | exact di |
Showing the most recent 17 of 29 linked reports.
Showing 1–15 of 17
Regulatory clearances
Predicate lineage
Cited as predicate by: K151396, K152876, K180169, K182918, K192804, K193595, K200910, K201271, K222115, K222358, K222603, K232437, K241399, K243577, K253359
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 |
|---|---|---|---|---|
| 2021-06-21 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2021-06-21 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2017-02-13 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2017-02-13 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2016-02-23 | VAI | Voluntary action indicated | Penumbra Inc. | 0 |
| 2016-02-23 | VAI | Voluntary action indicated | Penumbra Inc. | 0 |
| 2015-08-04 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2015-08-04 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2015-07-15 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2015-07-15 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2014-04-30 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2014-04-30 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2012-02-27 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2012-02-27 | NAI | No action indicated | Penumbra Inc. | 0 |
| 2010-08-24 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2010-08-24 | VAI | Voluntary action indicated | Penumbra Inc. | 1 |
| 2009-12-31 | WL | Warning Letter | Penumbra Inc. | — |
| 2009-12-31 | WL | Warning Letter | Penumbra Inc. | — |
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