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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.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

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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