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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
2023-11-02VAIVoluntary action indicatedGyrus ACMI, Inc.3
2022-05-02NAINo action indicatedGyrus ACMI, Inc.0
2020-01-14NAINo action indicatedGyrus ACMI, Inc.0
2018-05-23NAINo action indicatedGyrus ACMI, Inc.0
2018-04-17VAIVoluntary action indicatedGyrus ACMI, Inc.1
2017-07-27NAINo action indicatedGyrus ACMI, Inc.0
2016-08-17NAINo action indicatedGyrus ACMI, Inc.0
2016-07-01NAINo action indicatedGyrus ACMI, Inc.0
2015-12-11NAINo action indicatedGyrus ACMI, Inc.0
2015-04-03VAIVoluntary action indicatedGyrus ACMI, Inc.1
2015-03-20NAINo action indicatedGyrus ACMI, Inc.0
2013-09-18VAIVoluntary action indicatedGyrus ACMI, Inc.4
2013-06-21VAIVoluntary action indicatedGyrus ACMI, Inc.1
2013-06-11VAIVoluntary action indicatedGyrus Acmi, Inc.2
2012-08-31NAINo action indicatedGyrus ACMI, Inc.0
2012-06-14VAIVoluntary action indicatedGyrus ACMI, Inc.2
2011-06-13NAINo action indicatedGyrus ACMI, Inc.0
2010-09-15NAINo action indicatedGyrus ACMI, Inc.0
2010-06-24NAINo action indicatedGyrus Acmi, Inc.0
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