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.
- United StatesOption Elite Retrievable Vena Cava Filter System00886333217151
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.
344 linked reportsMalfunction 176Injury 165Death 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2020-03 | 1 | — |
| 2020-04 | 1 | — |
| 2020-05 | 2 | — |
| 2020-06 | 12 | — |
| 2020-07 | 13 | — |
| 2020-08 | 10 | — |
| 2020-09 | 6 | — |
| 2020-10 | 56 | — |
| 2020-11 | 7 | — |
| 2020-12 | 15 | — |
| 2021-01 | 2 | — |
| 2021-02 | 1 | — |
| 2021-03 | 2 | — |
| 2021-05 | 5 | — |
| 2021-06 | 21 | — |
| 2021-07 | 6 | — |
| 2021-08 | 2 | — |
| 2021-09 | 3 | — |
| 2021-11 | 9 | — |
| 2021-12 | 16 | — |
| 2022-01 | 4 | — |
| 2022-03 | 2 | — |
| 2022-04 | 1 | — |
| 2022-05 | 2 | — |
| 2022-06 | 1 | — |
| 2022-07 | 2 | — |
| 2022-08 | 6 | — |
| 2022-09 | 2 | — |
| 2022-10 | 3 | — |
| 2022-11 | 1 | — |
| 2022-12 | 2 | — |
| 2023-01 | 4 | — |
| 2023-02 | 3 | — |
| 2023-04 | 2 | — |
| 2023-05 | 4 | — |
| 2023-06 | 10 | — |
| 2023-07 | 3 | — |
| 2023-08 | 6 | — |
| 2023-09 | 2 | — |
| 2023-10 | 7 | — |
| 2023-11 | 2 | — |
| 2023-12 | 7 | — |
| 2024-01 | 2 | — |
| 2024-03 | 5 | — |
| 2024-04 | 6 | — |
| 2024-05 | 3 | — |
| 2024-06 | 3 | — |
| 2024-07 | 2 | — |
| 2024-08 | 4 | — |
| 2024-09 | 3 | — |
| 2024-10 | 2 | — |
| 2024-12 | 4 | — |
| 2025-01 | 1 | — |
| 2025-02 | 2 | — |
| 2025-03 | 2 | — |
| 2025-05 | 3 | — |
| 2025-06 | 3 | — |
| 2025-07 | 4 | — |
| 2025-08 | 1 | — |
| 2025-09 | 3 | — |
| 2025-10 | 3 | — |
| 2025-11 | 2 | — |
| 2025-12 | 3 | — |
| 2026-01 | 3 | — |
| 2026-02 | 3 | — |
| 2026-03 | 4 | — |
| 2026-04 | 2 | — |
| 2026-05 | 5 | — |
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 |
|---|---|---|---|---|
| 2026-05-29 | 0001625425-2026-00969 | Malfunction | Available | exact di |
| 2026-05-09 | 0001625425-2026-00963 | Malfunction | Available | exact di |
| 2026-05-09 | 0001625425-2026-00964 | Malfunction | Available | exact di |
| 2026-05-09 | 0001625425-2026-00965 | Injury | Available | exact di |
| 2026-05-08 | 0001625425-2026-00962 | Injury | Available | exact di |
| 2026-04-30 | 0001625425-2026-00955 | Malfunction | Available | exact di |
| 2026-04-23 | 0001625425-2026-00954 | Injury | Available | exact di |
| 2026-03-30 | 0001625425-2026-00951 | Malfunction | Available | exact di |
| 2026-03-30 | 0001625425-2026-00947 | Injury | Available | exact di |
| 2026-03-30 | 0001625425-2026-00950 | Injury | Available | exact di |
| 2026-03-07 | 0001625425-2026-00945 | Malfunction | Available | exact di |
| 2026-02-14 | 0001625425-2026-00940 | Malfunction | Available | exact di |
| 2026-02-13 | 0001625425-2026-00939 | Injury | Available | exact di |
| 2026-02-11 | 0001625425-2026-00936 | Injury | Available | exact di |
| 2026-01-29 | 0001625425-2026-00929 | Malfunction | Available | exact di |
Showing the most recent 200 of 344 linked reports.
Showing 1–15 of 200
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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