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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
2024-05-30NAINo action indicatedDeVilbiss Healthcare LLC0
2022-08-17OAIOfficial action indicatedDeVilbiss Healthcare LLC4
2021-11-23WLWarning LetterDeVilbiss Healthcare LLC—
2021-08-25OAIOfficial action indicatedDeVilbiss Healthcare LLC9
2016-02-24VAIVoluntary action indicatedDrive DeVilbiss Healthcare0
2016-01-28NAINo action indicatedDeVilbiss Healthcare LLC0
2014-07-18VAIVoluntary action indicatedDrive DeVilbiss Healthcare3
2012-10-10WLWarning LetterDrive DeVilbiss Healthcare—
2012-08-31OAIOfficial action indicatedDrive DeVilbiss Healthcare8
2012-02-22NAINo action indicatedDeVilbiss Healthcare LLC0
2010-03-31NAINo action indicatedDeVilbiss Healthcare LLC0
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