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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.

45 linked reportsMalfunction 45
91827362021-12: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-05: 6 reports for this device; peer average 6/device2023-06: 36 reports for this device; peer average 36/device2024-04: 2 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-11: 1 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device1208010305060405110307
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-1201
2022-0803
2023-0101
2023-0302
2023-0566
2023-063636
2024-0422
2024-0501
2024-1111
2025-0302
2025-0702
This device (reports/month)Average device in GBQ (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-11-220001625425-2024-01153MalfunctionAvailableexact di
2024-04-110001625425-2024-00980MalfunctionAvailableexact di
2023-06-020001625425-2023-01078MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01086MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01079MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01089MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01083MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01080MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01081MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01088MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01082MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01087MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01085MalfunctionAvailablecatalog number
2023-06-020001625425-2023-01084MalfunctionAvailablecatalog number
2023-05-040001625425-2023-01040MalfunctionAvailablecatalog number

Showing the most recent 17 of 45 linked reports.

Showing 1–15 of 17
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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