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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
2025-09-19NAINo action indicatedCarefusion Corporation1
2025-09-19NAINo action indicatedCarefusion Corporation1
2025-09-18NAINo action indicatedCareFusion DR 203 LTD0
2023-09-29VAIVoluntary action indicatedCareFusion 213, LLC5
2022-12-08NAINo action indicatedCAREFUSION0
2022-12-08NAINo action indicatedCAREFUSION0
2022-10-19VAIVoluntary action indicatedCarefusion 2200 Inc2
2018-11-15NAINo action indicatedCarefusion 2200 Inc0
2018-09-28VAIVoluntary action indicatedCarefusion Corporation2
2018-09-28VAIVoluntary action indicatedCarefusion Corporation2
2016-12-15NAINo action indicatedCareFusion 213, LLC0
2015-05-07VAIVoluntary action indicatedCarefusion 2200 Inc2
2014-12-11NAINo action indicatedCareFusion Inc0
2014-10-30NAINo action indicatedCareFusion DR 203 LTD0
2014-06-20VAIVoluntary action indicatedCarefusion Corporation1
2014-06-20VAIVoluntary action indicatedCarefusion Corporation1
2014-06-06WLWarning LetterCarefusion 2200 Inc—
2014-03-11NAINo action indicatedCareFusion 213, LLC0
2013-11-05OAIOfficial action indicatedCarefusion 2200 Inc7
2011-09-07VAIVoluntary action indicatedCarefusion 2200 Inc3
2010-07-30OAIOfficial action indicatedCarefusion Corporation0
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