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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
2024-12-11NAINo action indicatedIBP Medical Gmbh0
2019-06-14NAINo action indicatedMesa Laboratories, Inc., Bozeman Manufacturing Facility0
2018-05-25VAIVoluntary action indicatedIBP Medical Gmbh3
2018-03-16VAIVoluntary action indicatedMesa Laboratories, Inc.3
2018-03-16VAIVoluntary action indicatedMesa Laboratories, Inc.3
2016-12-07VAIVoluntary action indicatedMesa Laboratories, Inc., Bozeman Manufacturing Facility0
2015-05-14NAINo action indicatedMesa Laboratories, Inc., Bozeman Manufacturing Facility0
2015-03-05VAIVoluntary action indicatedMesa Laboratories, Inc.5
2015-03-05VAIVoluntary action indicatedMesa Laboratories, Inc.5
2012-09-20NAINo action indicatedMesa Laboratories, Inc., Bozeman Manufacturing Facility0
2012-08-29VAIVoluntary action indicatedMesa Laboratories, Inc.12
2012-08-29VAIVoluntary action indicatedMesa Laboratories, Inc.12
2012-05-11VAIVoluntary action indicatedMesa Laboratories, Inc., Bozeman Manufacturing Facility0
2011-07-13NAINo action indicatedMesa Laboratories, Inc., Bozeman Manufacturing Facility0
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