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 | 0 | 2.22 |
| 2025-12 | 1 | 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
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-10-04 | Z-0409-2024 | Class II | Open, Classified | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.Distribution: US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam | 33,327 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-09 | 2015691-2025-09859 | 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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