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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
2023-06-15OAIOfficial action indicatedDatascope Corp.6
2023-06-15OAIOfficial action indicatedDatascope Corp.6
2022-01-21OAIOfficial action indicatedDatascope Corp.13
2022-01-21OAIOfficial action indicatedDatascope Corp.13
2019-02-06WLWarning LetterDatascope Corp.—
2019-02-06WLWarning LetterDatascope Corp.—
2018-10-03OAIOfficial action indicatedDatascope Corp.9
2018-10-03OAIOfficial action indicatedDatascope Corp.9
2018-09-11WLWarning LetterDatascope Corp.—
2018-09-11WLWarning LetterDatascope Corp.—
2018-06-11OAIOfficial action indicatedDatascope Corp.11
2018-06-11OAIOfficial action indicatedDatascope Corp.11
2015-02-03INJInjunctionDatascope Corp.—
2015-02-03INJInjunctionDatascope Corp.—
2013-10-17OAIOfficial action indicatedDatascope Corp.4
2010-04-13VAIVoluntary action indicatedDatascope Corp.2
2010-04-13VAIVoluntary action indicatedDatascope Corp.2
2010-04-01NAINo action indicatedDatascope Corp.0
2010-04-01NAINo action indicatedDatascope Corp.0
2010-03-24NAINo action indicatedDatascope Corp.0
2010-03-24NAINo action indicatedDatascope Corp.0
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