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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.

3 linked reportsInjury 3
24792019-02: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1.8/device2019-12: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 5/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.5/device2020-08: 0 reports for this device; peer average 6/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 2.5/device2020-11: 0 reports for this device; peer average 3.4/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.33/device2021-04: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/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 5/device2022-06: 0 reports for this device; peer average 2.2/device2022-07: 0 reports for this device; peer average 4/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 1.8/device2022-10: 0 reports for this device; peer average 2.29/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1.17/device2023-01: 0 reports for this device; peer average 1.5/device2023-02: 0 reports for this device; peer average 3.33/device2023-03: 0 reports for this device; peer average 1.83/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.33/device2023-06: 0 reports for this device; peer average 1.88/device2023-07: 0 reports for this device; peer average 2.19/device2023-08: 0 reports for this device; peer average 1.67/device2023-09: 0 reports for this device; peer average 6.43/device2023-10: 0 reports for this device; peer average 1.86/device2023-11: 0 reports for this device; peer average 1.68/device2023-12: 0 reports for this device; peer average 1.67/device2024-01: 0 reports for this device; peer average 1.64/device2024-02: 0 reports for this device; peer average 1.71/device2024-03: 0 reports for this device; peer average 1.83/device2024-04: 0 reports for this device; peer average 2.67/device2024-05: 0 reports for this device; peer average 2.5/device2024-06: 0 reports for this device; peer average 2.55/device2024-07: 0 reports for this device; peer average 2.57/device2024-08: 0 reports for this device; peer average 8.67/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2.1/device2024-11: 0 reports for this device; peer average 1.44/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 3 reports for this device; peer average 3.55/device2025-02: 0 reports for this device; peer average 1.86/device2025-03: 0 reports for this device; peer average 1.82/device2025-04: 0 reports for this device; peer average 1.67/device2025-05: 0 reports for this device; peer average 1.63/device2025-06: 0 reports for this device; peer average 2.44/device2025-07: 0 reports for this device; peer average 1.86/device2025-08: 0 reports for this device; peer average 1.4/device2025-09: 0 reports for this device; peer average 2.86/device2025-10: 0 reports for this device; peer average 1.8/device2025-11: 0 reports for this device; peer average 2.25/device2025-12: 0 reports for this device; peer average 2.5/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.33/device2026-03: 0 reports for this device; peer average 3.67/device2026-04: 0 reports for this device; peer average 3.33/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device0205081202060708091011120102030405060809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0501
2019-0801.8
2019-1201
2020-0205
2020-0602
2020-0701.5
2020-0806
2020-0901.5
2020-1002.5
2020-1103.4
2020-1201
2021-0101
2021-0202
2021-0301.33
2021-0402
2021-0502
2021-0602
2021-0801
2021-0901
2021-1003
2021-1101
2021-1201
2022-0101
2022-0201
2022-0301
2022-0401
2022-0505
2022-0602.2
2022-0704
2022-0803
2022-0901.8
2022-1002.29
2022-1102
2022-1201.17
2023-0101.5
2023-0203.33
2023-0301.83
2023-0401
2023-0501.33
2023-0601.88
2023-0702.19
2023-0801.67
2023-0906.43
2023-1001.86
2023-1101.68
2023-1201.67
2024-0101.64
2024-0201.71
2024-0301.83
2024-0402.67
2024-0502.5
2024-0602.55
2024-0702.57
2024-0808.67
2024-0902
2024-1002.1
2024-1101.44
2024-1201.63
2025-0133.55
2025-0201.86
2025-0301.82
2025-0401.67
2025-0501.63
2025-0602.44
2025-0701.86
2025-0801.4
2025-0902.86
2025-1001.8
2025-1102.25
2025-1202.5
2026-0102
2026-0201.33
2026-0303.67
2026-0403.33
2026-0502
2026-0602
This device (reports/month)Average device in FTD, GDI (reports/device/month)
Failure-mode summaryAI-generated

3 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-01-023011706110-2025-00002InjuryAvailablecatalog number

Showing the most recent 1 of 3 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2018-12-13NAINo action indicatedAtriCure, Inc.0
2018-12-13NAINo action indicatedAtriCure, Inc.0
2018-03-09VAIVoluntary action indicatedAtriCure, Inc.0
2018-03-09VAIVoluntary action indicatedAtriCure, Inc.3
2018-03-09VAIVoluntary action indicatedAtriCure, Inc.3
2018-03-09VAIVoluntary action indicatedAtriCure, Inc.0
2016-10-13NAINo action indicatedAtriCure, Inc.0
2016-10-13NAINo action indicatedAtriCure, Inc.0
2016-08-29VAIVoluntary action indicatedAtriCure, Inc.3
2016-08-29VAIVoluntary action indicatedAtriCure, Inc.3
2013-02-26NAINo action indicatedAtriCure, Inc.0
2013-02-26NAINo action indicatedAtriCure, Inc.0
2013-01-18VAIVoluntary action indicatedAtriCure, Inc.1
2013-01-18VAIVoluntary action indicatedAtriCure, Inc.1
2011-04-01NAINo action indicatedAtriCure, Inc.0
2011-04-01NAINo action indicatedAtriCure, Inc.0
2011-02-22VAIVoluntary action indicatedAtriCure, Inc.0
2011-02-22VAIVoluntary action indicatedAtriCure, Inc.0
2010-06-21NAINo action indicatedAtriCure, Inc.0
2010-06-21NAINo action indicatedAtriCure, Inc.0
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