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.
174 linked reportsMalfunction 155Injury 18Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.3 |
| 2019-02 | 0 | 3.05 |
| 2019-03 | 0 | 2.93 |
| 2019-04 | 0 | 3.33 |
| 2019-05 | 0 | 3.01 |
| 2019-06 | 0 | 2.94 |
| 2019-07 | 1 | 3.3 |
| 2019-08 | 0 | 3.5 |
| 2019-09 | 0 | 2.93 |
| 2019-10 | 1 | 3.38 |
| 2019-11 | 0 | 2.95 |
| 2019-12 | 0 | 2.75 |
| 2020-01 | 0 | 3.64 |
| 2020-02 | 0 | 3.06 |
| 2020-03 | 0 | 3 |
| 2020-04 | 0 | 3.42 |
| 2020-05 | 4 | 3.2 |
| 2020-06 | 4 | 3.96 |
| 2020-07 | 12 | 4.38 |
| 2020-08 | 2 | 3.59 |
| 2020-09 | 3 | 3.8 |
| 2020-10 | 2 | 2.54 |
| 2020-11 | 1 | 2.26 |
| 2020-12 | 4 | 2.24 |
| 2021-01 | 6 | 2.67 |
| 2021-02 | 2 | 2.5 |
| 2021-03 | 4 | 2.92 |
| 2021-04 | 4 | 2.59 |
| 2021-05 | 6 | 2.19 |
| 2021-06 | 0 | 2.52 |
| 2021-07 | 2 | 3.03 |
| 2021-08 | 1 | 2.74 |
| 2021-09 | 5 | 2.93 |
| 2021-10 | 0 | 2.93 |
| 2021-11 | 6 | 3.19 |
| 2021-12 | 0 | 2.89 |
| 2022-01 | 0 | 2.66 |
| 2022-02 | 2 | 2.49 |
| 2022-03 | 0 | 2.54 |
| 2022-04 | 0 | 2.79 |
| 2022-05 | 4 | 2.57 |
| 2022-06 | 2 | 2.79 |
| 2022-07 | 2 | 3.21 |
| 2022-08 | 0 | 2.44 |
| 2022-09 | 0 | 2.54 |
| 2022-10 | 2 | 1.98 |
| 2022-11 | 8 | 2.72 |
| 2022-12 | 8 | 2.84 |
| 2023-01 | 2 | 2.95 |
| 2023-02 | 4 | 2.67 |
| 2023-03 | 0 | 2.76 |
| 2023-04 | 2 | 2.38 |
| 2023-05 | 0 | 2.66 |
| 2023-06 | 0 | 2.84 |
| 2023-07 | 1 | 2.56 |
| 2023-08 | 11 | 2.97 |
| 2023-09 | 0 | 2.71 |
| 2023-10 | 1 | 2.57 |
| 2023-11 | 1 | 2.58 |
| 2023-12 | 0 | 2.5 |
| 2024-01 | 3 | 2.21 |
| 2024-02 | 1 | 2.45 |
| 2024-03 | 10 | 2.42 |
| 2024-04 | 1 | 2.69 |
| 2024-05 | 0 | 2.6 |
| 2024-06 | 1 | 2.99 |
| 2024-07 | 0 | 2.42 |
| 2024-08 | 1 | 2.65 |
| 2024-09 | 0 | 2.31 |
| 2024-10 | 3 | 2.74 |
| 2024-11 | 2 | 3.13 |
| 2024-12 | 0 | 2.46 |
| 2025-01 | 7 | 2.74 |
| 2025-02 | 2 | 3.06 |
| 2025-03 | 1 | 3.24 |
| 2025-04 | 2 | 2.45 |
| 2025-05 | 3 | 2.96 |
| 2025-06 | 2 | 2.64 |
| 2025-07 | 0 | 2.69 |
| 2025-08 | 1 | 2.48 |
| 2025-09 | 4 | 2.61 |
| 2025-10 | 1 | 2.55 |
| 2025-11 | 2 | 3.39 |
| 2025-12 | 0 | 2.63 |
| 2026-01 | 3 | 3.13 |
| 2026-02 | 2 | 2.68 |
| 2026-03 | 0 | 2.6 |
| 2026-04 | 0 | 3.16 |
| 2026-05 | 0 | 2.43 |
| 2026-06 | 2 | 3.04 |
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 |
|---|---|---|---|---|
| 2026-06-29 | 0001625425-2026-00980 | Malfunction | — | exact di |
| 2026-06-24 | 0001625425-2026-00978 | Malfunction | — | exact di |
| 2026-02-11 | 0001625425-2026-00937 | Malfunction | Available | exact di |
| 2026-02-07 | 0001625425-2026-00931 | Malfunction | Available | exact di |
| 2026-01-09 | 0001625425-2026-00923 | Malfunction | Available | exact di |
| 2026-01-09 | 0001625425-2026-00925 | Injury | Available | exact di |
| 2026-01-07 | 0001625425-2026-00922 | Injury | Available | exact di |
| 2025-11-22 | 0001625425-2025-01134 | Injury | Available | exact di |
| 2025-11-21 | 0001625425-2025-01133 | Injury | Available | exact di |
| 2025-10-15 | 0001625425-2025-01095 | Injury | Available | exact di |
| 2025-09-15 | 23051145 | Malfunction | Available | catalog number |
| 2025-09-05 | 22977406 | Malfunction | Available | catalog number |
| 2025-08-12 | 0001625425-2025-01065 | Malfunction | Available | exact di |
| 2025-06-12 | 0001625425-2025-01031 | Injury | Available | exact di |
| 2025-06-05 | 0001625425-2025-01024 | Malfunction | Available | exact di |
Showing the most recent 123 of 174 linked reports.
Showing 1–15 of 123
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2021-11-04 | NAI | No action indicated | Argon Medical Devices, Inc | 0 |
| 2021-11-04 | NAI | No action indicated | Argon Medical Devices, Inc | 0 |
| 2016-05-27 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 2 |
| 2016-05-27 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 2 |
| 2016-05-04 | NAI | No action indicated | Argon Medical Devices Inc. | 0 |
| 2016-05-04 | NAI | No action indicated | Argon Medical Devices Inc. | 0 |
| 2014-07-03 | WL | Warning Letter | Argon Medical Devices, Inc | — |
| 2014-07-03 | WL | Warning Letter | Argon Medical Devices, Inc | — |
| 2013-12-13 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 3 |
| 2013-12-13 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 3 |
| 2012-01-18 | VAI | Voluntary action indicated | Argon Medical Devices Inc. | 3 |
| 2012-01-18 | VAI | Voluntary action indicated | Argon Medical Devices Inc. | 3 |
| 2011-05-18 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 1 |
| 2011-05-18 | VAI | Voluntary action indicated | Argon Medical Devices, Inc | 1 |
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