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.
4 linked reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.89 |
| 2019-02 | 0 | 1.73 |
| 2019-03 | 0 | 3.86 |
| 2019-04 | 0 | 2.7 |
| 2019-05 | 0 | 2 |
| 2019-06 | 0 | 3.1 |
| 2019-07 | 0 | 3.36 |
| 2019-08 | 0 | 2.67 |
| 2019-09 | 0 | 2.44 |
| 2019-10 | 0 | 3.71 |
| 2019-11 | 0 | 2.21 |
| 2019-12 | 0 | 2.67 |
| 2020-01 | 0 | 1.86 |
| 2020-02 | 0 | 2.35 |
| 2020-03 | 0 | 3.75 |
| 2020-04 | 0 | 2.4 |
| 2020-05 | 0 | 2.5 |
| 2020-06 | 0 | 1.92 |
| 2020-07 | 0 | 2.21 |
| 2020-08 | 0 | 2.62 |
| 2020-09 | 0 | 1.91 |
| 2020-10 | 0 | 2.61 |
| 2020-11 | 0 | 3.62 |
| 2020-12 | 0 | 2.7 |
| 2021-01 | 0 | 3.2 |
| 2021-02 | 0 | 2.9 |
| 2021-03 | 0 | 2.8 |
| 2021-04 | 0 | 3.38 |
| 2021-05 | 0 | 6.85 |
| 2021-06 | 0 | 2.83 |
| 2021-07 | 0 | 2.39 |
| 2021-08 | 0 | 6.69 |
| 2021-09 | 0 | 4.67 |
| 2021-10 | 0 | 2.67 |
| 2021-11 | 0 | 3.16 |
| 2021-12 | 0 | 5.08 |
| 2022-01 | 0 | 5 |
| 2022-02 | 0 | 4 |
| 2022-03 | 0 | 4.94 |
| 2022-04 | 0 | 4.11 |
| 2022-05 | 0 | 3.74 |
| 2022-06 | 0 | 2.76 |
| 2022-07 | 0 | 2.82 |
| 2022-08 | 0 | 2.25 |
| 2022-09 | 0 | 3.69 |
| 2022-10 | 0 | 3.14 |
| 2022-11 | 0 | 2.33 |
| 2022-12 | 0 | 3.6 |
| 2023-01 | 0 | 3.33 |
| 2023-02 | 0 | 4 |
| 2023-03 | 0 | 3.65 |
| 2023-04 | 0 | 3 |
| 2023-05 | 0 | 3.22 |
| 2023-06 | 0 | 3.86 |
| 2023-07 | 0 | 2.42 |
| 2023-08 | 0 | 2.42 |
| 2023-09 | 0 | 2.57 |
| 2023-10 | 0 | 2.23 |
| 2023-11 | 0 | 4.13 |
| 2023-12 | 0 | 8.07 |
| 2024-01 | 0 | 4.16 |
| 2024-02 | 0 | 4.64 |
| 2024-03 | 0 | 4.11 |
| 2024-04 | 0 | 5.53 |
| 2024-05 | 0 | 6.13 |
| 2024-06 | 0 | 6.18 |
| 2024-07 | 0 | 3.06 |
| 2024-08 | 0 | 4.33 |
| 2024-09 | 0 | 5.83 |
| 2024-10 | 0 | 3.82 |
| 2024-11 | 0 | 4.5 |
| 2024-12 | 0 | 2.95 |
| 2025-01 | 0 | 4.35 |
| 2025-02 | 0 | 3.19 |
| 2025-03 | 0 | 3.36 |
| 2025-04 | 0 | 3.79 |
| 2025-05 | 0 | 4.65 |
| 2025-06 | 1 | 1.74 |
| 2025-07 | 0 | 3 |
| 2025-08 | 0 | 2.67 |
| 2025-09 | 0 | 2.44 |
| 2025-10 | 0 | 2.31 |
| 2025-11 | 0 | 3.73 |
| 2025-12 | 1 | 2.66 |
| 2026-01 | 0 | 3.71 |
| 2026-02 | 1 | 3.34 |
| 2026-03 | 1 | 2.3 |
| 2026-04 | 0 | 2.31 |
| 2026-05 | 0 | 2.66 |
| 2026-06 | 0 | 2.23 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-25 | 2015691-2026-13491 | Malfunction | Available | exact di |
| 2026-02-13 | 2015691-2026-11074 | Malfunction | Available | exact di |
| 2025-12-05 | 2015691-2025-09782 | Malfunction | Available | exact di |
| 2025-06-09 | 2015691-2025-04675 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-15 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2024-08-15 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2022-12-06 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2022-12-06 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2021-11-19 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2021-11-19 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2019-08-19 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2019-08-19 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2019-06-14 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 3 |
| 2019-06-14 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 3 |
| 2018-02-01 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2018-02-01 | NAI | No action indicated | Edwards Lifesciences, LLC | 0 |
| 2017-07-14 | NAI | No action indicated | Edwards Lifesciences (Singapore) Pte. Ltd | 0 |
| 2016-05-20 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 3 |
| 2016-05-20 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 3 |
| 2016-02-12 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 0 |
| 2016-02-12 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 0 |
| 2015-12-17 | NAI | No action indicated | Edwards Lifesciences (Singapore) Pte. Ltd | 0 |
| 2015-11-20 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 5 |
| 2015-11-20 | VAI | Voluntary action indicated | Edwards Lifesciences, LLC | 3 |
| 2013-05-24 | WL | Warning Letter | Edwards Lifesciences, LLC | — |
| 2013-05-24 | WL | Warning Letter | Edwards Lifesciences, LLC | — |
| 2010-03-01 | WL | Warning Letter | Edwards Lifesciences, LLC | — |
| 2010-03-01 | WL | Warning Letter | Edwards Lifesciences, LLC | — |
Similar devices
- Cardio Server EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
- 12 Pneumatic Endo probes for Endo PAT 2000 ITAMAR MEDICAL LTD
- AT-Patch ATsens Co., Ltd.
- AT-Patch ATsens Co., Ltd.
- AT-Patch ATsens Co., Ltd.
- AT-Report ATsens Co., Ltd.
- ATACC-C130A ATsens Co., Ltd.
- AVVIGO™ Guidance System BOSTON SCIENTIFIC CORPORATION
- AVVIGO™ Guidance System BOSTON SCIENTIFIC CORPORATION
- AVVIGO™ Guidance System BOSTON SCIENTIFIC CORPORATION
- AVVIGO™ Guidance System BOSTON SCIENTIFIC CORPORATION
- AVVIGO™ Guidance System II BOSTON SCIENTIFIC CORPORATION
Select up to two to place side-by-side with this device.