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.
30 linked reportsMalfunction 28Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.53 |
| 2019-02 | 0 | 1.39 |
| 2019-03 | 0 | 1.92 |
| 2019-04 | 0 | 1.58 |
| 2019-05 | 0 | 1.77 |
| 2019-06 | 0 | 2.3 |
| 2019-07 | 0 | 1.7 |
| 2019-08 | 0 | 1.85 |
| 2019-09 | 0 | 1.85 |
| 2019-10 | 0 | 1.83 |
| 2019-11 | 0 | 1.65 |
| 2019-12 | 0 | 1.59 |
| 2020-01 | 0 | 2.25 |
| 2020-02 | 0 | 2.08 |
| 2020-03 | 0 | 2.29 |
| 2020-04 | 0 | 1.89 |
| 2020-05 | 0 | 2.06 |
| 2020-06 | 0 | 2.56 |
| 2020-07 | 0 | 2.13 |
| 2020-08 | 0 | 2.46 |
| 2020-09 | 0 | 1.95 |
| 2020-10 | 0 | 1.96 |
| 2020-11 | 0 | 1.81 |
| 2020-12 | 0 | 1.67 |
| 2021-01 | 0 | 1.71 |
| 2021-02 | 0 | 2.09 |
| 2021-03 | 0 | 2.5 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 2.21 |
| 2021-06 | 0 | 1.87 |
| 2021-07 | 0 | 1.93 |
| 2021-08 | 0 | 2.42 |
| 2021-09 | 3 | 2.18 |
| 2021-10 | 0 | 2.07 |
| 2021-11 | 3 | 1.65 |
| 2021-12 | 0 | 1.71 |
| 2022-01 | 3 | 1.53 |
| 2022-02 | 1 | 1.92 |
| 2022-03 | 0 | 2.65 |
| 2022-04 | 3 | 1.91 |
| 2022-05 | 0 | 1.46 |
| 2022-06 | 0 | 2.32 |
| 2022-07 | 6 | 2.21 |
| 2022-08 | 0 | 2.17 |
| 2022-09 | 0 | 1.7 |
| 2022-10 | 0 | 2.09 |
| 2022-11 | 0 | 2.37 |
| 2022-12 | 0 | 1.91 |
| 2023-01 | 0 | 1.91 |
| 2023-02 | 0 | 1.76 |
| 2023-03 | 0 | 2.19 |
| 2023-04 | 0 | 2.39 |
| 2023-05 | 0 | 2.35 |
| 2023-06 | 0 | 2.06 |
| 2023-07 | 0 | 2.55 |
| 2023-08 | 0 | 2.62 |
| 2023-09 | 0 | 1.94 |
| 2023-10 | 0 | 2.42 |
| 2023-11 | 0 | 2.08 |
| 2023-12 | 0 | 2.38 |
| 2024-01 | 0 | 2.26 |
| 2024-02 | 0 | 2.23 |
| 2024-03 | 0 | 1.95 |
| 2024-04 | 0 | 2.32 |
| 2024-05 | 0 | 2.09 |
| 2024-06 | 0 | 2.06 |
| 2024-07 | 2 | 2.62 |
| 2024-08 | 2 | 2.15 |
| 2024-09 | 0 | 2.62 |
| 2024-10 | 0 | 2.58 |
| 2024-11 | 2 | 2.67 |
| 2024-12 | 2 | 2.44 |
| 2025-01 | 0 | 3.34 |
| 2025-02 | 3 | 2.13 |
| 2025-03 | 0 | 2.9 |
| 2025-04 | 0 | 2.6 |
| 2025-05 | 0 | 2.71 |
| 2025-06 | 0 | 3.18 |
| 2025-07 | 0 | 3.18 |
| 2025-08 | 0 | 3.24 |
| 2025-09 | 0 | 2.63 |
| 2025-10 | 0 | 2.54 |
| 2025-11 | 0 | 3.33 |
| 2025-12 | 0 | 2.69 |
| 2026-01 | 0 | 4.26 |
| 2026-02 | 0 | 3.21 |
| 2026-03 | 0 | 3.52 |
| 2026-04 | 0 | 2.64 |
| 2026-05 | 0 | 3.04 |
| 2026-06 | 0 | 3.78 |
Failure-mode summaryAI-generated
30 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-02-18 | 0001625425-2025-00946 | Malfunction | Available | exact di |
| 2025-02-14 | 0001625425-2025-00935 | Malfunction | Available | model number |
| 2024-12-01 | 0001625425-2024-01158 | Malfunction | Available | exact di |
| 2024-11-01 | 20587263 | Malfunction | Available | catalog number |
| 2024-08-22 | 0001625425-2024-01087 | Malfunction | Available | exact di |
| 2024-07-11 | 0001625425-2024-01065 | Injury | Available | exact di |
| 2022-07-28 | 0001625425-2022-01045 | Malfunction | Available | catalog number |
| 2022-07-28 | 0001625425-2022-01046 | Malfunction | Available | catalog number |
| 2022-04-14 | 0001625425-2022-00978 | Malfunction | Available | catalog number |
| 2022-02-14 | 0001625425-2022-00951 | Malfunction | Available | exact di |
| 2022-01-13 | 0001625425-2022-00926 | Malfunction | Available | catalog number |
| 2021-11-24 | 0001625425-2021-01133 | Malfunction | Available | catalog number |
| 2021-09-17 | 0001625425-2021-01083 | Malfunction | Available | catalog number |
Showing the most recent 13 of 30 linked reports.
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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