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 27Injury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 3 |
| 2019-08 | 0 | 2 |
| 2019-10 | 0 | 1 |
| 2019-11 | 0 | 3 |
| 2019-12 | 0 | 2 |
| 2020-01 | 1 | 1.5 |
| 2020-02 | 1 | 1 |
| 2020-03 | 4 | 3 |
| 2020-04 | 2 | 1.5 |
| 2020-05 | 2 | 2 |
| 2020-06 | 3 | 3 |
| 2020-07 | 3 | 3 |
| 2020-09 | 1 | 5.5 |
| 2020-10 | 0 | 2 |
| 2020-12 | 0 | 2 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 2 |
| 2021-04 | 1 | 1 |
| 2021-06 | 0 | 2 |
| 2021-07 | 0 | 3.5 |
| 2021-08 | 0 | 1 |
| 2021-10 | 2 | 2.33 |
| 2021-11 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 3 |
| 2022-06 | 0 | 2 |
| 2022-08 | 0 | 2.2 |
| 2022-09 | 0 | 1 |
| 2022-10 | 3 | 3 |
| 2022-11 | 0 | 1 |
| 2023-01 | 0 | 2 |
| 2023-03 | 0 | 2 |
| 2023-04 | 3 | 2 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-08 | 2 | 2 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 2 |
| 2024-01 | 0 | 1 |
| 2024-05 | 0 | 2 |
| 2024-06 | 2 | 2 |
| 2024-11 | 0 | 1 |
| 2024-12 | 0 | 3 |
| 2025-01 | 0 | 3 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 1.5 |
| 2025-05 | 0 | 1 |
| 2025-06 | 0 | 1 |
| 2025-07 | 0 | 1 |
| 2025-11 | 0 | 5 |
| 2026-01 | 0 | 1 |
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 |
|---|---|---|---|---|
| 2024-06-01 | 0001625425-2024-01035 | Malfunction | Available | exact di |
| 2023-08-17 | 0001625425-2023-01161 | Malfunction | Available | exact di |
| 2023-04-06 | 0001625425-2023-01015 | Malfunction | Available | catalog number |
| 2022-10-23 | 0001625425-2022-01117 | Malfunction | Available | catalog number |
| 2021-10-27 | 0001625425-2021-01109 | Injury | Available | exact di |
| 2021-04-08 | 1625425-2021-00907 | Malfunction | Available | catalog number |
| 2020-09-01 | 1625425-2020-00494 | Injury | Available | catalog number |
| 2020-07-24 | 1625425-2020-00446 | Malfunction | Available | catalog number |
| 2020-07-17 | 1625425-2020-00418 | Malfunction | Available | catalog number |
| 2020-07-17 | 1625425-2020-00417 | Malfunction | Available | catalog number |
| 2020-06-30 | 1625425-2020-00367 | Malfunction | Available | catalog number |
| 2020-06-30 | 1625425-2020-00368 | Malfunction | Available | catalog number |
| 2020-06-30 | 1625425-2020-00366 | Malfunction | Available | catalog number |
| 2020-05-20 | 1625425-2020-00324 | Malfunction | Available | catalog number |
| 2020-05-06 | 1625425-2020-00314 | Malfunction | Available | catalog number |
Showing the most recent 23 of 30 linked reports.
Showing 1–15 of 23
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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