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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
2023-12-05VAIVoluntary action indicatedInstrumed International Inc5
2022-06-28VAIVoluntary action indicatedAvalign Integrated Medical Solutions, Inc.3
2019-11-20VAIVoluntary action indicatedInstrumed International Inc2
2018-10-25NAINo action indicatedInstrumed GmbH0
2016-11-30NAINo action indicatedInstrumed International Inc0
2015-09-22NAINo action indicatedMillennium Surgical Corp0
2015-01-29NAINo action indicatedInstrumed GmbH0
2014-03-28WLWarning LetterInstrumed GmbH—
2013-08-20VAIVoluntary action indicatedInstrumed International Inc17
2013-08-01OAIOfficial action indicatedInstrumed GmbH0
2013-04-24VAIVoluntary action indicatedAvalign Integrated Medical Solutions, Inc.4
2011-02-28NAINo action indicatedInstrumed International Inc0
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