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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
2025-02-03VAIVoluntary action indicatedRemel Inc.2
2023-03-03NAINo action indicatedRemel, Inc0
2019-11-20VAIVoluntary action indicatedRemel Inc.2
2017-04-12VAIVoluntary action indicatedRemel Inc.2
2015-10-23VAIVoluntary action indicatedRemel, Inc3
2014-07-03VAIVoluntary action indicatedRemel, Inc5
2013-06-25VAIVoluntary action indicatedRemel, Inc4
2013-03-07NAINo action indicatedRemel, Inc0
2010-03-18VAIVoluntary action indicatedRemel, Inc6
2010-03-16VAIVoluntary action indicatedRemel Inc.3
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