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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
2024-04-24WLWarning LetterCardinal Health 200, LLC—
2024-04-24WLWarning LetterCardinal Health 200, LLC—
2023-12-20OAIOfficial action indicatedCardinal Health 200, LLC3
2023-12-20OAIOfficial action indicatedCardinal Health 200, LLC3
2023-10-26VAIVoluntary action indicatedAero-Med LLC2
2023-05-05NAINo action indicatedCardinal Health 200, LLC0
2023-05-05NAINo action indicatedCardinal Health 200, LLC0
2023-01-12NAINo action indicatedLudlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)0
2020-02-19NAINo action indicatedCardinal Health Inc.0
2018-12-21VAIVoluntary action indicatedAero-Med LLC2
2017-11-15VAIVoluntary action indicatedCardinal Health LLC1
2017-07-13NAINo action indicatedCardinal Health D.R. 203 II LTD0
2017-01-25VAIVoluntary action indicatedCardinal Health4
2016-11-16NAINo action indicatedCardinal Health Ireland Manufacturing Limited0
2016-11-16VAIVoluntary action indicatedCardinal Health PR 218 Inc0
2016-08-25NAINo action indicatedCardinal Health 200, LLC0
2016-08-25NAINo action indicatedCardinal Health 200, LLC0
2016-08-23NAINo action indicatedCardinal Health 200, LLC0
2016-05-12VAIVoluntary action indicatedCardinal Health0
2016-03-23NAINo action indicatedCardinal Health LLC0
2016-01-28VAIVoluntary action indicatedLudlow Technical Products Canada, Ltd. (A Division of Cardinal Health LLC)2
2015-11-18NAINo action indicatedCardinal Health0
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