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Acumen IQ

Model AIQS6 · Edwards Lifesciences LLC · DI 00690103201079

DRS — Transducer, Blood-Pressure, Extravascular · Class II · 21 CFR 870.2850

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2023-10-04Z-0409-2024Class IIOpen, ClassifiedTheir is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.code info di

Adverse-event reports — MAUDE (1)

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.

Malfunction: 1

24572019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 2.33/device2021-11: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 7/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 2.5/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 2.33/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1.5/device2023-03: 0 reports for this device; peer average 2.33/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 2.75/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1.67/device2023-08: 0 reports for this device; peer average 1.33/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2.4/device2023-11: 0 reports for this device; peer average 2.4/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 0 reports for this device; peer average 2.5/device2024-03: 0 reports for this device; peer average 1.2/device2024-04: 0 reports for this device; peer average 1.86/device2024-05: 0 reports for this device; peer average 5.14/device2024-06: 0 reports for this device; peer average 3.3/device2024-07: 0 reports for this device; peer average 3.2/device2024-08: 0 reports for this device; peer average 2.27/device2024-09: 0 reports for this device; peer average 1.14/device2024-10: 0 reports for this device; peer average 1.67/device2024-11: 0 reports for this device; peer average 1.67/device2024-12: 0 reports for this device; peer average 5.5/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2.71/device2025-03: 0 reports for this device; peer average 1.33/device2025-04: 0 reports for this device; peer average 1.43/device2025-05: 0 reports for this device; peer average 2.27/device2025-06: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 1.33/device2025-08: 0 reports for this device; peer average 2.22/device2025-09: 0 reports for this device; peer average 2.25/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 2.22/device2025-12: 1 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 5.25/device2026-02: 0 reports for this device; peer average 6.83/device2026-03: 0 reports for this device; peer average 3.13/device2026-04: 0 reports for this device; peer average 2.36/device2026-05: 0 reports for this device; peer average 2.33/device2026-06: 0 reports for this device; peer average 2.29/device010203040608091002030406091202040607101101020304050607091011120103040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0201
2019-0302
2019-0402
2019-0601
2019-0801
2019-0902
2019-1001
2020-0201
2020-0302
2020-0401
2020-0601
2020-0901.5
2020-1201
2021-0202
2021-0401
2021-0603
2021-0701
2021-1002.33
2021-1101
2022-0107
2022-0203
2022-0301
2022-0401
2022-0502.5
2022-0602
2022-0701
2022-0902.17
2022-1001
2022-1102.33
2022-1201
2023-0101.5
2023-0302.33
2023-0401
2023-0502.75
2023-0601
2023-0701.67
2023-0801.33
2023-0901
2023-1002.4
2023-1102.4
2023-1202
2024-0101.33
2024-0202.5
2024-0301.2
2024-0401.86
2024-0505.14
2024-0603.3
2024-0703.2
2024-0802.27
2024-0901.14
2024-1001.67
2024-1101.67
2024-1205.5
2025-0102
2025-0202.71
2025-0301.33
2025-0401.43
2025-0502.27
2025-0601.5
2025-0701.33
2025-0802.22
2025-0902.25
2025-1001.5
2025-1102.22
2025-1211
2026-0105.25
2026-0206.83
2026-0303.13
2026-0402.36
2026-0502.33
2026-0602.29
This device (reports/month)Average device in DRS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K152980 — cited as predicate by K180881, K183646, K190205, K203224, K231248, K242909

Lineage extracted from public 510(k) summary text (heuristic).

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