Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- European UnionOption EliteB-00886333222346
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.
66 linked reportsInjury 33Malfunction 33
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6.5 |
| 2019-02 | 0 | 4.38 |
| 2019-03 | 0 | 8.1 |
| 2019-04 | 0 | 10.93 |
| 2019-05 | 3 | 6.82 |
| 2019-06 | 0 | 7.85 |
| 2019-07 | 0 | 11.53 |
| 2019-08 | 0 | 9.71 |
| 2019-09 | 0 | 14.71 |
| 2019-10 | 0 | 11.63 |
| 2019-11 | 0 | 9.77 |
| 2019-12 | 1 | 9.6 |
| 2020-01 | 2 | 17.29 |
| 2020-02 | 0 | 14.6 |
| 2020-03 | 1 | 9.91 |
| 2020-04 | 0 | 14.76 |
| 2020-05 | 0 | 5.29 |
| 2020-06 | 0 | 7.86 |
| 2020-07 | 0 | 19.07 |
| 2020-08 | 0 | 7.11 |
| 2020-09 | 0 | 7 |
| 2020-10 | 18 | 26.67 |
| 2020-11 | 0 | 9.5 |
| 2020-12 | 3 | 8.95 |
| 2021-01 | 0 | 11.38 |
| 2021-02 | 0 | 18.95 |
| 2021-03 | 0 | 11.24 |
| 2021-04 | 0 | 9.75 |
| 2021-05 | 0 | 8 |
| 2021-06 | 3 | 14.19 |
| 2021-07 | 3 | 11.14 |
| 2021-08 | 2 | 8.06 |
| 2021-09 | 6 | 7.27 |
| 2021-10 | 0 | 6.26 |
| 2021-11 | 0 | 9.09 |
| 2021-12 | 0 | 8.44 |
| 2022-01 | 0 | 5.14 |
| 2022-02 | 0 | 4.74 |
| 2022-03 | 0 | 4.86 |
| 2022-04 | 0 | 6 |
| 2022-05 | 3 | 11.64 |
| 2022-06 | 3 | 4.77 |
| 2022-07 | 0 | 4.36 |
| 2022-08 | 0 | 4.7 |
| 2022-09 | 0 | 4 |
| 2022-10 | 0 | 3.17 |
| 2022-11 | 0 | 1.83 |
| 2022-12 | 0 | 4.44 |
| 2023-01 | 0 | 3.69 |
| 2023-02 | 0 | 3.4 |
| 2023-03 | 0 | 3.6 |
| 2023-04 | 0 | 2.83 |
| 2023-05 | 0 | 4 |
| 2023-06 | 0 | 7.22 |
| 2023-07 | 0 | 3.8 |
| 2023-08 | 0 | 3 |
| 2023-09 | 2 | 2.08 |
| 2023-10 | 2 | 3.78 |
| 2023-11 | 0 | 2.67 |
| 2023-12 | 2 | 4.78 |
| 2024-01 | 0 | 1.6 |
| 2024-02 | 0 | 3.2 |
| 2024-03 | 2 | 3.5 |
| 2024-04 | 1 | 3.57 |
| 2024-05 | 2 | 2.5 |
| 2024-06 | 0 | 4.17 |
| 2024-07 | 0 | 2.4 |
| 2024-08 | 0 | 3.14 |
| 2024-09 | 0 | 3 |
| 2024-10 | 0 | 2.83 |
| 2024-11 | 1 | 2.38 |
| 2024-12 | 0 | 4.4 |
| 2025-01 | 0 | 1.5 |
| 2025-02 | 0 | 1.57 |
| 2025-03 | 0 | 3.6 |
| 2025-04 | 0 | 1.57 |
| 2025-05 | 0 | 4.33 |
| 2025-06 | 4 | 4.2 |
| 2025-07 | 2 | 3.14 |
| 2025-08 | 0 | 2.75 |
| 2025-09 | 0 | 3.57 |
| 2025-10 | 0 | 3.8 |
| 2025-11 | 0 | 3.6 |
| 2025-12 | 0 | 2.83 |
| 2026-01 | 0 | 3.5 |
| 2026-02 | 0 | 4.2 |
| 2026-03 | 0 | 6.2 |
| 2026-04 | 0 | 2.25 |
| 2026-05 | 0 | 3.33 |
| 2026-06 | 0 | 2.25 |
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 |
|---|---|---|---|---|
| 2025-07-01 | 0001625425-2025-01046 | Malfunction | Available | exact di |
| 2025-06-20 | 0001625425-2025-01042 | Malfunction | Available | exact di |
| 2025-06-02 | 22122771 | Malfunction | Available | catalog number |
| 2024-05-08 | 0001625425-2024-01018 | Malfunction | Available | exact di |
| 2024-04-03 | 0001625425-2024-00976 | Malfunction | Available | exact di |
| 2024-03-28 | 18989992 | Malfunction | Available | catalog number |
| 2023-12-02 | 0001625425-2023-01250 | Malfunction | Available | exact di |
| 2023-10-02 | 0001625425-2023-01212 | Malfunction | Available | exact di |
| 2023-09-27 | 0001625425-2023-01206 | Malfunction | Available | exact di |
| 2022-06-20 | 0001625425-2022-01026 | Malfunction | Available | catalog number |
| 2022-05-24 | 0001625425-2022-01010 | Malfunction | Available | catalog number |
| 2021-09-23 | 0001625425-2021-01084 | Malfunction | Available | catalog number |
| 2021-09-03 | 0001625425-2021-01074 | Injury | Available | catalog number |
| 2021-08-25 | 12364709 | Malfunction | Available | catalog number |
| 2021-07-21 | 0001625425-2021-01037 | Malfunction | Available | catalog number |
Showing the most recent 30 of 66 linked reports.
Showing 1–15 of 30
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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