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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.

27 linked reportsMalfunction 18Injury 9
34691031372019-01: 0 reports for this device; peer average 11.13/device2019-02: 0 reports for this device; peer average 4.13/device2019-03: 0 reports for this device; peer average 2.6/device2019-04: 0 reports for this device; peer average 3.54/device2019-05: 0 reports for this device; peer average 7.38/device2019-06: 0 reports for this device; peer average 41.85/device2019-07: 0 reports for this device; peer average 9.24/device2019-08: 0 reports for this device; peer average 63.43/device2019-09: 0 reports for this device; peer average 30.31/device2019-10: 0 reports for this device; peer average 11.12/device2019-11: 1 reports for this device; peer average 33.61/device2019-12: 0 reports for this device; peer average 46.68/device2020-01: 0 reports for this device; peer average 42.17/device2020-02: 0 reports for this device; peer average 34.08/device2020-03: 0 reports for this device; peer average 137.06/device2020-04: 0 reports for this device; peer average 64.38/device2020-05: 0 reports for this device; peer average 33.55/device2020-06: 0 reports for this device; peer average 66.13/device2020-07: 0 reports for this device; peer average 57.25/device2020-08: 0 reports for this device; peer average 33.63/device2020-09: 0 reports for this device; peer average 40.24/device2020-10: 0 reports for this device; peer average 22.5/device2020-11: 0 reports for this device; peer average 28.13/device2020-12: 0 reports for this device; peer average 15.74/device2021-01: 0 reports for this device; peer average 20.28/device2021-02: 0 reports for this device; peer average 12.97/device2021-03: 0 reports for this device; peer average 12.7/device2021-04: 0 reports for this device; peer average 9.2/device2021-05: 0 reports for this device; peer average 4.29/device2021-06: 0 reports for this device; peer average 4.73/device2021-07: 3 reports for this device; peer average 5.88/device2021-08: 0 reports for this device; peer average 6.48/device2021-09: 0 reports for this device; peer average 10.65/device2021-10: 0 reports for this device; peer average 5.43/device2021-11: 1 reports for this device; peer average 4.23/device2021-12: 0 reports for this device; peer average 7.62/device2022-01: 0 reports for this device; peer average 6.9/device2022-02: 0 reports for this device; peer average 8.39/device2022-03: 0 reports for this device; peer average 5.7/device2022-04: 0 reports for this device; peer average 3.76/device2022-05: 0 reports for this device; peer average 3/device2022-06: 3 reports for this device; peer average 2.68/device2022-07: 0 reports for this device; peer average 3.74/device2022-08: 3 reports for this device; peer average 3.95/device2022-09: 0 reports for this device; peer average 5.42/device2022-10: 0 reports for this device; peer average 5.95/device2022-11: 0 reports for this device; peer average 3.96/device2022-12: 3 reports for this device; peer average 5.74/device2023-01: 0 reports for this device; peer average 3.73/device2023-02: 0 reports for this device; peer average 6.29/device2023-03: 0 reports for this device; peer average 5.15/device2023-04: 0 reports for this device; peer average 6.26/device2023-05: 0 reports for this device; peer average 5.15/device2023-06: 0 reports for this device; peer average 5.86/device2023-07: 0 reports for this device; peer average 4.95/device2023-08: 0 reports for this device; peer average 5.79/device2023-09: 0 reports for this device; peer average 4.77/device2023-10: 0 reports for this device; peer average 8.78/device2023-11: 0 reports for this device; peer average 7.22/device2023-12: 0 reports for this device; peer average 7.63/device2024-01: 0 reports for this device; peer average 9.97/device2024-02: 0 reports for this device; peer average 5.16/device2024-03: 0 reports for this device; peer average 4.15/device2024-04: 4 reports for this device; peer average 7.54/device2024-05: 0 reports for this device; peer average 5.44/device2024-06: 0 reports for this device; peer average 11.85/device2024-07: 0 reports for this device; peer average 6.11/device2024-08: 0 reports for this device; peer average 10.25/device2024-09: 0 reports for this device; peer average 13.25/device2024-10: 0 reports for this device; peer average 6.5/device2024-11: 0 reports for this device; peer average 4.24/device2024-12: 0 reports for this device; peer average 5.88/device2025-01: 0 reports for this device; peer average 4.57/device2025-02: 0 reports for this device; peer average 6.66/device2025-03: 0 reports for this device; peer average 11.29/device2025-04: 7 reports for this device; peer average 8.63/device2025-05: 0 reports for this device; peer average 8.45/device2025-06: 0 reports for this device; peer average 6.93/device2025-07: 0 reports for this device; peer average 6.06/device2025-08: 0 reports for this device; peer average 12.38/device2025-09: 0 reports for this device; peer average 6.9/device2025-10: 0 reports for this device; peer average 5.83/device2025-11: 0 reports for this device; peer average 8.5/device2025-12: 0 reports for this device; peer average 9.26/device2026-01: 2 reports for this device; peer average 15.75/device2026-02: 0 reports for this device; peer average 16.68/device2026-03: 0 reports for this device; peer average 11.69/device2026-04: 0 reports for this device; peer average 15.03/device2026-05: 0 reports for this device; peer average 15.8/device2026-06: 0 reports for this device; peer average 23.48/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01011.13
2019-0204.13
2019-0302.6
2019-0403.54
2019-0507.38
2019-06041.85
2019-0709.24
2019-08063.43
2019-09030.31
2019-10011.12
2019-11133.61
2019-12046.68
2020-01042.17
2020-02034.08
2020-030137.06
2020-04064.38
2020-05033.55
2020-06066.13
2020-07057.25
2020-08033.63
2020-09040.24
2020-10022.5
2020-11028.13
2020-12015.74
2021-01020.28
2021-02012.97
2021-03012.7
2021-0409.2
2021-0504.29
2021-0604.73
2021-0735.88
2021-0806.48
2021-09010.65
2021-1005.43
2021-1114.23
2021-1207.62
2022-0106.9
2022-0208.39
2022-0305.7
2022-0403.76
2022-0503
2022-0632.68
2022-0703.74
2022-0833.95
2022-0905.42
2022-1005.95
2022-1103.96
2022-1235.74
2023-0103.73
2023-0206.29
2023-0305.15
2023-0406.26
2023-0505.15
2023-0605.86
2023-0704.95
2023-0805.79
2023-0904.77
2023-1008.78
2023-1107.22
2023-1207.63
2024-0109.97
2024-0205.16
2024-0304.15
2024-0447.54
2024-0505.44
2024-06011.85
2024-0706.11
2024-08010.25
2024-09013.25
2024-1006.5
2024-1104.24
2024-1205.88
2025-0104.57
2025-0206.66
2025-03011.29
2025-0478.63
2025-0508.45
2025-0606.93
2025-0706.06
2025-08012.38
2025-0906.9
2025-1005.83
2025-1108.5
2025-1209.26
2026-01215.75
2026-02016.68
2026-03011.69
2026-04015.03
2026-05015.8
2026-06023.48
This device (reports/month)Average device in KNW (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-01-280001625425-2026-00928MalfunctionAvailableexact di
2025-04-230001625425-2025-00995InjuryAvailableexact di
2025-04-230001625425-2025-00999InjuryAvailableexact di
2025-04-230001625425-2025-00996InjuryAvailableexact di
2025-04-230001625425-2025-00998InjuryAvailableexact di
2025-04-230001625425-2025-00997InjuryAvailableexact di
2024-04-260001625425-2024-01002InjuryAvailableexact di
2024-04-250001625425-2024-00996MalfunctionAvailableexact di
2022-12-120001625425-2022-01159MalfunctionAvailablecatalog number
2022-08-150001625425-2022-01061MalfunctionAvailablecatalog number
2022-06-270001625425-2022-01035MalfunctionAvailablecatalog number
2021-11-09MW5105233MalfunctionAvailablecatalog number
2021-07-150001625425-2021-01026MalfunctionAvailablecatalog number
2019-11-081625425-2019-00279MalfunctionAvailablecatalog number

Showing the most recent 14 of 27 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2021-11-04NAINo action indicatedArgon Medical Devices, Inc0
2021-11-04NAINo action indicatedArgon Medical Devices, Inc0
2016-05-27VAIVoluntary action indicatedArgon Medical Devices, Inc2
2016-05-27VAIVoluntary action indicatedArgon Medical Devices, Inc2
2016-05-04NAINo action indicatedArgon Medical Devices Inc.0
2016-05-04NAINo action indicatedArgon Medical Devices Inc.0
2014-07-03WLWarning LetterArgon Medical Devices, Inc—
2014-07-03WLWarning LetterArgon Medical Devices, Inc—
2013-12-13VAIVoluntary action indicatedArgon Medical Devices, Inc3
2013-12-13VAIVoluntary action indicatedArgon Medical Devices, Inc3
2012-01-18VAIVoluntary action indicatedArgon Medical Devices Inc.3
2012-01-18VAIVoluntary action indicatedArgon Medical Devices Inc.3
2011-05-18VAIVoluntary action indicatedArgon Medical Devices, Inc1
2011-05-18VAIVoluntary action indicatedArgon Medical Devices, Inc1
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