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-00886333217151
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.
1,163 linked reportsInjury 622Malfunction 533Death 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 6.5 |
| 2019-02 | 1 | 4.38 |
| 2019-03 | 14 | 8.1 |
| 2019-04 | 15 | 10.93 |
| 2019-05 | 17 | 6.82 |
| 2019-06 | 0 | 7.85 |
| 2019-07 | 6 | 11.53 |
| 2019-08 | 14 | 9.71 |
| 2019-09 | 0 | 14.71 |
| 2019-10 | 2 | 11.63 |
| 2019-11 | 2 | 9.77 |
| 2019-12 | 19 | 9.6 |
| 2020-01 | 36 | 17.29 |
| 2020-02 | 33 | 14.6 |
| 2020-03 | 18 | 9.91 |
| 2020-04 | 10 | 14.76 |
| 2020-05 | 5 | 5.29 |
| 2020-06 | 35 | 7.86 |
| 2020-07 | 39 | 19.07 |
| 2020-08 | 30 | 7.11 |
| 2020-09 | 20 | 7 |
| 2020-10 | 169 | 26.67 |
| 2020-11 | 21 | 9.5 |
| 2020-12 | 45 | 8.95 |
| 2021-01 | 6 | 11.38 |
| 2021-02 | 6 | 18.95 |
| 2021-03 | 6 | 11.24 |
| 2021-04 | 0 | 9.75 |
| 2021-05 | 15 | 8 |
| 2021-06 | 64 | 14.19 |
| 2021-07 | 20 | 11.14 |
| 2021-08 | 9 | 8.06 |
| 2021-09 | 12 | 7.27 |
| 2021-10 | 5 | 6.26 |
| 2021-11 | 30 | 9.09 |
| 2021-12 | 48 | 8.44 |
| 2022-01 | 12 | 5.14 |
| 2022-02 | 0 | 4.74 |
| 2022-03 | 9 | 4.86 |
| 2022-04 | 6 | 6 |
| 2022-05 | 7 | 11.64 |
| 2022-06 | 8 | 4.77 |
| 2022-07 | 9 | 4.36 |
| 2022-08 | 18 | 4.7 |
| 2022-09 | 6 | 4 |
| 2022-10 | 10 | 3.17 |
| 2022-11 | 3 | 1.83 |
| 2022-12 | 6 | 4.44 |
| 2023-01 | 15 | 3.69 |
| 2023-02 | 9 | 3.4 |
| 2023-03 | 0 | 3.6 |
| 2023-04 | 6 | 2.83 |
| 2023-05 | 14 | 4 |
| 2023-06 | 30 | 7.22 |
| 2023-07 | 9 | 3.8 |
| 2023-08 | 10 | 3 |
| 2023-09 | 4 | 2.08 |
| 2023-10 | 13 | 3.78 |
| 2023-11 | 5 | 2.67 |
| 2023-12 | 14 | 4.78 |
| 2024-01 | 3 | 1.6 |
| 2024-02 | 0 | 3.2 |
| 2024-03 | 10 | 3.5 |
| 2024-04 | 9 | 3.57 |
| 2024-05 | 6 | 2.5 |
| 2024-06 | 7 | 4.17 |
| 2024-07 | 5 | 2.4 |
| 2024-08 | 8 | 3.14 |
| 2024-09 | 6 | 3 |
| 2024-10 | 5 | 2.83 |
| 2024-11 | 2 | 2.38 |
| 2024-12 | 12 | 4.4 |
| 2025-01 | 2 | 1.5 |
| 2025-02 | 3 | 1.57 |
| 2025-03 | 7 | 3.6 |
| 2025-04 | 1 | 1.57 |
| 2025-05 | 7 | 4.33 |
| 2025-06 | 6 | 4.2 |
| 2025-07 | 8 | 3.14 |
| 2025-08 | 4 | 2.75 |
| 2025-09 | 9 | 3.57 |
| 2025-10 | 7 | 3.8 |
| 2025-11 | 3 | 3.6 |
| 2025-12 | 6 | 2.83 |
| 2026-01 | 7 | 3.5 |
| 2026-02 | 5 | 4.2 |
| 2026-03 | 8 | 6.2 |
| 2026-04 | 3 | 2.25 |
| 2026-05 | 9 | 3.33 |
| 2026-06 | 0 | 2.25 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-09-12 | Z-0589-2026 | Class II | Open, Classified | Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is appliedDistribution: U.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S. (international) to countries of: China, Panama and Trinidad and Tobago | Total devices 1821 (US=1794 and O.U.S.=27) units | code info di |
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 | 0001625425-2026-00947 | Injury | Available | exact di |
| 2026-03-30 | 0001625425-2026-00951 | Malfunction | 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 1,163 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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