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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
2025-07-10NAINo action indicatedDecimal LLC0
2023-10-20NAINo action indicatedQFIX0
2022-11-09NAINo action indicatedDecimal LLC0
2018-09-24NAINo action indicatedQFIX0
2018-02-23VAIVoluntary action indicatedDecimal LLC3
2016-02-10NAINo action indicatedMedTec LLC0
2016-02-10NAINo action indicatedMedTec LLC0
2015-05-01VAIVoluntary action indicatedDecimal LLC0
2012-06-29VAIVoluntary action indicatedDecimal LLC6
2011-01-07NAINo action indicatedMedTec LLC0
2011-01-07NAINo action indicatedMedTec LLC0
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