Skip to content
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
2016-07-22VAIVoluntary action indicatedThermotek, Inc.5
2016-07-22VAIVoluntary action indicatedThermotek, Inc.5
2013-11-06VAIVoluntary action indicatedThermotek, Inc.0
2013-11-06VAIVoluntary action indicatedThermotek, Inc.0
2010-08-25VAIVoluntary action indicatedThermotek, Inc.2
2010-08-25VAIVoluntary action indicatedThermotek, Inc.2
Similar devices
Select up to two to place side-by-side with this device.