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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
2026-05-26VAIVoluntary action indicatedBiowave Corporation3
2026-05-26VAIVoluntary action indicatedBiowave Corporation3
2023-06-21VAIVoluntary action indicatedBiowave Corporation4
2023-06-21VAIVoluntary action indicatedBiowave Corporation4
2017-04-27VAIVoluntary action indicatedBiowave Corporation2
2017-04-27VAIVoluntary action indicatedBiowave Corporation2
2013-08-28VAIVoluntary action indicatedBiowave Corporation6
2013-08-28VAIVoluntary action indicatedBiowave Corporation6
2011-02-18NAINo action indicatedBiowave Corporation0
2011-02-18NAINo action indicatedBiowave Corporation0
2010-07-28VAIVoluntary action indicatedBiowave Corporation2
2010-07-28VAIVoluntary action indicatedBiowave Corporation2
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