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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
2024-07-11OAIOfficial action indicatedMaquet Cardiovascular, LLC11
2024-07-11OAIOfficial action indicatedMaquet Cardiovascular, LLC11
2021-02-26VAIVoluntary action indicatedMaquet Cardiovascular, LLC10
2021-02-26VAIVoluntary action indicatedMaquet Cardiovascular, LLC10
2019-09-19VAIVoluntary action indicatedINTERVASCULAR, SAS3
2016-09-29OAIOfficial action indicatedMaquet Cardiovascular, LLC16
2016-09-29OAIOfficial action indicatedMaquet Cardiovascular, LLC16
2015-06-18NAINo action indicatedINTERVASCULAR, SAS0
2013-10-16OAIOfficial action indicatedMaquet Cardiovascular, LLC17
2013-10-16OAIOfficial action indicatedMaquet Cardiovascular, LLC17
2012-06-14OAIOfficial action indicatedMaquet Cardiovascular, LLC14
2012-06-14OAIOfficial action indicatedMaquet Cardiovascular, LLC14
2011-04-01OAIOfficial action indicatedMaquet Cardiovascular, LLC13
2011-04-01OAIOfficial action indicatedMaquet Cardiovascular, LLC13
2010-08-11WLWarning LetterMaquet Cardiovascular, LLC—
2010-08-11WLWarning LetterMaquet Cardiovascular, LLC—
2010-06-28NAINo action indicatedMaquet Cardiovascular0
2010-05-14OAIOfficial action indicatedMaquet Cardiovascular, LLC5
2010-05-14OAIOfficial action indicatedMaquet Cardiovascular, LLC5
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