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 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2 |
| 2019-04 | 0 | 2 |
| 2019-06 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 2 |
| 2019-10 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 0 | 2 |
| 2020-04 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-09 | 0 | 1.5 |
| 2020-12 | 0 | 1 |
| 2021-02 | 0 | 2 |
| 2021-04 | 0 | 1 |
| 2021-06 | 0 | 3 |
| 2021-07 | 0 | 1 |
| 2021-10 | 0 | 2.33 |
| 2021-11 | 0 | 1 |
| 2022-01 | 0 | 7 |
| 2022-02 | 0 | 3 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 2.5 |
| 2022-06 | 0 | 2 |
| 2022-07 | 0 | 1 |
| 2022-09 | 0 | 2.17 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 2.33 |
| 2022-12 | 0 | 1 |
| 2023-01 | 0 | 1.5 |
| 2023-03 | 0 | 2.33 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 2.75 |
| 2023-06 | 0 | 1 |
| 2023-07 | 0 | 1.67 |
| 2023-08 | 0 | 1.33 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 2.4 |
| 2023-11 | 0 | 2.4 |
| 2023-12 | 0 | 2 |
| 2024-01 | 0 | 1.33 |
| 2024-02 | 0 | 2.5 |
| 2024-03 | 0 | 1.2 |
| 2024-04 | 0 | 1.86 |
| 2024-05 | 0 | 5.14 |
| 2024-06 | 0 | 3.3 |
| 2024-07 | 0 | 3.2 |
| 2024-08 | 0 | 2.27 |
| 2024-09 | 0 | 1.14 |
| 2024-10 | 0 | 1.67 |
| 2024-11 | 0 | 1.67 |
| 2024-12 | 0 | 5.5 |
| 2025-01 | 0 | 2 |
| 2025-02 | 0 | 2.71 |
| 2025-03 | 0 | 1.33 |
| 2025-04 | 0 | 1.43 |
| 2025-05 | 0 | 2.27 |
| 2025-06 | 0 | 1.5 |
| 2025-07 | 0 | 1.33 |
| 2025-08 | 0 | 2.22 |
| 2025-09 | 0 | 2.25 |
| 2025-10 | 0 | 1.5 |
| 2025-11 | 1 | 2.22 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 5.25 |
| 2026-02 | 0 | 6.83 |
| 2026-03 | 0 | 3.13 |
| 2026-04 | 0 | 2.36 |
| 2026-05 | 0 | 2.33 |
| 2026-06 | 0 | 2.29 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-11-25 | 2015691-2025-09562 | Malfunction | Available | exact di |
Regulatory clearances
Predicate lineage
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
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 | — |
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