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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
2022-07-18VAIVoluntary action indicatedCardinal Health2
2022-06-24NAINo action indicatedCardinal Health0
2020-02-19NAINo action indicatedCardinal Health Inc.0
2017-11-15VAIVoluntary action indicatedCardinal Health LLC1
2017-08-30NAINo action indicatedCardinal Health LLC0
2017-02-15NAINo action indicatedCardinal Health0
2017-01-25VAIVoluntary action indicatedCardinal Health4
2016-05-12VAIVoluntary action indicatedCardinal Health0
2016-03-23NAINo action indicatedCardinal Health LLC0
2016-03-17NAINo action indicatedCardinal Health LLC.0
2015-11-18NAINo action indicatedCardinal Health0
2015-09-23NAINo action indicatedCardinal Health0
2015-09-03NAINo action indicatedCardinal Health0
2015-07-17NAINo action indicatedCardinal Health Inc.0
2015-04-17VAIVoluntary action indicatedCardinal Health LLC0
2015-03-26VAIVoluntary action indicatedCardinal Health, Inc4
2013-12-05NAINo action indicatedCardinal Health0
2013-09-09NAINo action indicatedCardinal Health0
2012-10-31NAINo action indicatedCardinal Health Inc.0
2012-10-30VAIVoluntary action indicatedCardinal Health1
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