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.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
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 | — |
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