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ACUMEN IQ

Model AIQSFM6AZ5 · Edwards Lifesciences LLC · DI 00690103205787

DQK — Computer, Diagnostic, Programmable · Class II · 21 CFR 870.1425

QMS — Adjunctive Open Loop Fluid Therapy Recommender · Class II · 21 CFR 870.5600

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

24682019-01: 0 reports for this device; peer average 3.89/device2019-02: 0 reports for this device; peer average 1.73/device2019-03: 0 reports for this device; peer average 3.86/device2019-04: 0 reports for this device; peer average 2.7/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 3.1/device2019-07: 0 reports for this device; peer average 3.36/device2019-08: 0 reports for this device; peer average 2.67/device2019-09: 0 reports for this device; peer average 2.44/device2019-10: 0 reports for this device; peer average 3.71/device2019-11: 0 reports for this device; peer average 2.21/device2019-12: 0 reports for this device; peer average 2.67/device2020-01: 0 reports for this device; peer average 1.86/device2020-02: 0 reports for this device; peer average 2.35/device2020-03: 0 reports for this device; peer average 3.75/device2020-04: 0 reports for this device; peer average 2.4/device2020-05: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 1.92/device2020-07: 0 reports for this device; peer average 2.21/device2020-08: 0 reports for this device; peer average 2.62/device2020-09: 0 reports for this device; peer average 1.91/device2020-10: 0 reports for this device; peer average 2.61/device2020-11: 0 reports for this device; peer average 3.62/device2020-12: 0 reports for this device; peer average 2.7/device2021-01: 0 reports for this device; peer average 3.2/device2021-02: 0 reports for this device; peer average 2.9/device2021-03: 0 reports for this device; peer average 2.8/device2021-04: 0 reports for this device; peer average 3.38/device2021-05: 0 reports for this device; peer average 6.85/device2021-06: 0 reports for this device; peer average 2.83/device2021-07: 0 reports for this device; peer average 2.39/device2021-08: 0 reports for this device; peer average 6.69/device2021-09: 0 reports for this device; peer average 4.67/device2021-10: 0 reports for this device; peer average 2.67/device2021-11: 0 reports for this device; peer average 3.16/device2021-12: 0 reports for this device; peer average 5.08/device2022-01: 0 reports for this device; peer average 5/device2022-02: 0 reports for this device; peer average 4/device2022-03: 0 reports for this device; peer average 4.94/device2022-04: 0 reports for this device; peer average 4.11/device2022-05: 0 reports for this device; peer average 3.74/device2022-06: 0 reports for this device; peer average 2.76/device2022-07: 0 reports for this device; peer average 2.82/device2022-08: 0 reports for this device; peer average 2.25/device2022-09: 0 reports for this device; peer average 3.69/device2022-10: 0 reports for this device; peer average 3.14/device2022-11: 0 reports for this device; peer average 2.33/device2022-12: 0 reports for this device; peer average 3.6/device2023-01: 0 reports for this device; peer average 3.33/device2023-02: 0 reports for this device; peer average 4/device2023-03: 0 reports for this device; peer average 3.65/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 3.22/device2023-06: 0 reports for this device; peer average 3.86/device2023-07: 0 reports for this device; peer average 2.42/device2023-08: 0 reports for this device; peer average 2.42/device2023-09: 0 reports for this device; peer average 2.57/device2023-10: 0 reports for this device; peer average 2.23/device2023-11: 0 reports for this device; peer average 4.13/device2023-12: 0 reports for this device; peer average 8.07/device2024-01: 0 reports for this device; peer average 4.16/device2024-02: 0 reports for this device; peer average 4.64/device2024-03: 0 reports for this device; peer average 4.11/device2024-04: 0 reports for this device; peer average 5.53/device2024-05: 0 reports for this device; peer average 6.13/device2024-06: 0 reports for this device; peer average 6.18/device2024-07: 0 reports for this device; peer average 3.06/device2024-08: 0 reports for this device; peer average 4.33/device2024-09: 0 reports for this device; peer average 5.83/device2024-10: 0 reports for this device; peer average 3.82/device2024-11: 0 reports for this device; peer average 4.5/device2024-12: 0 reports for this device; peer average 2.95/device2025-01: 0 reports for this device; peer average 4.35/device2025-02: 0 reports for this device; peer average 3.19/device2025-03: 0 reports for this device; peer average 3.36/device2025-04: 0 reports for this device; peer average 3.79/device2025-05: 0 reports for this device; peer average 4.65/device2025-06: 0 reports for this device; peer average 1.74/device2025-07: 0 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 2.67/device2025-09: 0 reports for this device; peer average 2.44/device2025-10: 0 reports for this device; peer average 2.31/device2025-11: 0 reports for this device; peer average 3.73/device2025-12: 0 reports for this device; peer average 2.66/device2026-01: 0 reports for this device; peer average 3.71/device2026-02: 0 reports for this device; peer average 3.34/device2026-03: 0 reports for this device; peer average 2.3/device2026-04: 0 reports for this device; peer average 2.31/device2026-05: 0 reports for this device; peer average 2.66/device2026-06: 0 reports for this device; peer average 2.23/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.89
2019-0201.73
2019-0303.86
2019-0402.7
2019-0502
2019-0603.1
2019-0703.36
2019-0802.67
2019-0902.44
2019-1003.71
2019-1102.21
2019-1202.67
2020-0101.86
2020-0202.35
2020-0303.75
2020-0402.4
2020-0502.5
2020-0601.92
2020-0702.21
2020-0802.62
2020-0901.91
2020-1002.61
2020-1103.62
2020-1202.7
2021-0103.2
2021-0202.9
2021-0302.8
2021-0403.38
2021-0506.85
2021-0602.83
2021-0702.39
2021-0806.69
2021-0904.67
2021-1002.67
2021-1103.16
2021-1205.08
2022-0105
2022-0204
2022-0304.94
2022-0404.11
2022-0503.74
2022-0602.76
2022-0702.82
2022-0802.25
2022-0903.69
2022-1003.14
2022-1102.33
2022-1203.6
2023-0103.33
2023-0204
2023-0303.65
2023-0403
2023-0503.22
2023-0603.86
2023-0702.42
2023-0802.42
2023-0902.57
2023-1002.23
2023-1104.13
2023-1208.07
2024-0104.16
2024-0204.64
2024-0304.11
2024-0405.53
2024-0506.13
2024-0606.18
2024-0703.06
2024-0804.33
2024-0905.83
2024-1003.82
2024-1104.5
2024-1202.95
2025-0104.35
2025-0203.19
2025-0303.36
2025-0403.79
2025-0504.65
2025-0601.74
2025-0703
2025-0802.67
2025-0902.44
2025-1002.31
2025-1103.73
2025-1202.66
2026-0103.71
2026-0203.34
2026-0302.3
2026-0402.31
2026-0502.66
2026-0602.23
This device (reports/month)Average device in DQK, QMS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Edwards Lifesciences LLC

  • Warning Letter 2013-05-24 Edwards Lifesciences, LLC
  • Warning Letter 2013-05-24 Edwards Lifesciences, LLC
  • Warning Letter 2010-03-01 Edwards Lifesciences, LLC
  • Warning Letter 2010-03-01 Edwards Lifesciences, LLC
  • NAI 2024-08-15 Edwards Lifesciences, LLC · 0 citations
  • NAI 2024-08-15 Edwards Lifesciences, LLC · 0 citations
  • NAI 2022-12-06 Edwards Lifesciences, LLC · 0 citations
  • NAI 2022-12-06 Edwards Lifesciences, LLC · 0 citations
  • NAI 2021-11-19 Edwards Lifesciences, LLC · 0 citations
  • NAI 2021-11-19 Edwards Lifesciences, LLC · 0 citations
  • NAI 2019-08-19 Edwards Lifesciences, LLC · 0 citations
  • NAI 2019-08-19 Edwards Lifesciences, LLC · 0 citations
  • VAI 2019-06-14 Edwards Lifesciences, LLC · 3 citations
  • VAI 2019-06-14 Edwards Lifesciences, LLC · 3 citations
  • NAI 2018-02-01 Edwards Lifesciences, LLC · 0 citations
  • NAI 2018-02-01 Edwards Lifesciences, LLC · 0 citations
  • NAI 2017-07-14 Edwards Lifesciences (Singapore) Pte. Ltd · 0 citations
  • VAI 2016-05-20 Edwards Lifesciences, LLC · 3 citations
  • VAI 2016-05-20 Edwards Lifesciences, LLC · 3 citations
  • VAI 2016-02-12 Edwards Lifesciences, LLC · 0 citations
  • VAI 2016-02-12 Edwards Lifesciences, LLC · 0 citations
  • NAI 2015-12-17 Edwards Lifesciences (Singapore) Pte. Ltd · 0 citations
  • VAI 2015-11-20 Edwards Lifesciences, LLC · 5 citations
  • VAI 2015-11-20 Edwards Lifesciences, LLC · 3 citations