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.
21 linked reportsMalfunction 21
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.17 |
| 2019-02 | 0 | 2.75 |
| 2019-03 | 0 | 3.02 |
| 2019-04 | 0 | 3.16 |
| 2019-05 | 0 | 2.59 |
| 2019-06 | 0 | 2.77 |
| 2019-07 | 0 | 2.83 |
| 2019-08 | 0 | 3.3 |
| 2019-09 | 0 | 2.66 |
| 2019-10 | 0 | 2.47 |
| 2019-11 | 0 | 2.53 |
| 2019-12 | 0 | 2.21 |
| 2020-01 | 0 | 2.52 |
| 2020-02 | 0 | 2.49 |
| 2020-03 | 0 | 2.5 |
| 2020-04 | 0 | 2.95 |
| 2020-05 | 0 | 2.22 |
| 2020-06 | 0 | 3.28 |
| 2020-07 | 0 | 3.37 |
| 2020-08 | 0 | 3.08 |
| 2020-09 | 0 | 3.63 |
| 2020-10 | 0 | 2.3 |
| 2020-11 | 0 | 2.23 |
| 2020-12 | 3 | 2.48 |
| 2021-01 | 0 | 2.98 |
| 2021-02 | 0 | 2.58 |
| 2021-03 | 0 | 2.99 |
| 2021-04 | 0 | 2.58 |
| 2021-05 | 0 | 2.13 |
| 2021-06 | 0 | 2.7 |
| 2021-07 | 0 | 3.3 |
| 2021-08 | 1 | 2.8 |
| 2021-09 | 0 | 2.61 |
| 2021-10 | 0 | 2.74 |
| 2021-11 | 0 | 2.5 |
| 2021-12 | 0 | 2.6 |
| 2022-01 | 0 | 2.98 |
| 2022-02 | 3 | 1.97 |
| 2022-03 | 0 | 1.98 |
| 2022-04 | 0 | 2.56 |
| 2022-05 | 0 | 2.41 |
| 2022-06 | 0 | 2.63 |
| 2022-07 | 0 | 2.13 |
| 2022-08 | 6 | 2.16 |
| 2022-09 | 3 | 2.25 |
| 2022-10 | 0 | 1.99 |
| 2022-11 | 0 | 2.69 |
| 2022-12 | 0 | 2.99 |
| 2023-01 | 0 | 2.66 |
| 2023-02 | 3 | 2.71 |
| 2023-03 | 0 | 3.22 |
| 2023-04 | 0 | 2.33 |
| 2023-05 | 0 | 2.53 |
| 2023-06 | 0 | 3.14 |
| 2023-07 | 0 | 2.29 |
| 2023-08 | 0 | 3.08 |
| 2023-09 | 0 | 2.61 |
| 2023-10 | 0 | 2.6 |
| 2023-11 | 0 | 2.92 |
| 2023-12 | 0 | 2.57 |
| 2024-01 | 0 | 1.94 |
| 2024-02 | 0 | 2.42 |
| 2024-03 | 0 | 2.48 |
| 2024-04 | 0 | 2.65 |
| 2024-05 | 0 | 2.55 |
| 2024-06 | 0 | 3.03 |
| 2024-07 | 0 | 2.43 |
| 2024-08 | 0 | 2.76 |
| 2024-09 | 0 | 2.52 |
| 2024-10 | 0 | 2.9 |
| 2024-11 | 0 | 3.39 |
| 2024-12 | 2 | 2.79 |
| 2025-01 | 0 | 2.85 |
| 2025-02 | 0 | 3.81 |
| 2025-03 | 0 | 3.82 |
| 2025-04 | 0 | 2.98 |
| 2025-05 | 0 | 3.48 |
| 2025-06 | 0 | 3.08 |
| 2025-07 | 0 | 2.54 |
| 2025-08 | 0 | 2.48 |
| 2025-09 | 0 | 2.55 |
| 2025-10 | 0 | 2.63 |
| 2025-11 | 0 | 3.96 |
| 2025-12 | 0 | 2.64 |
| 2026-01 | 0 | 3.4 |
| 2026-02 | 0 | 2.63 |
| 2026-03 | 0 | 2.87 |
| 2026-04 | 0 | 3.31 |
| 2026-05 | 0 | 2.41 |
| 2026-06 | 0 | 3.1 |
Failure-mode summaryAI-generated
21 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-12-08 | 0001625425-2024-01169 | Malfunction | Available | exact di |
| 2023-02-28 | 0001625425-2023-00974 | Malfunction | Available | catalog number |
| 2022-09-12 | 0001625425-2022-01085 | Malfunction | Available | catalog number |
| 2022-08-18 | 0001625425-2022-01066 | Malfunction | Available | catalog number |
| 2022-08-09 | 0001625425-2022-01058 | Malfunction | Available | catalog number |
| 2022-02-08 | 0001625425-2022-00946 | Malfunction | Available | catalog number |
| 2021-08-18 | 0001625425-2021-01065 | Malfunction | Available | exact di |
| 2020-12-18 | 1625425-2020-00802 | Malfunction | Available | catalog number |
Showing the most recent 8 of 21 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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