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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
2025-01-13NAINo action indicatedRichard Wolf Medical Instruments Corp.0
2023-04-19NAINo action indicatedRichard Wolf Medical Instruments Corp.0
2022-10-20OAIOfficial action indicatedRichard Wolf GmbH0
2022-10-20OAIOfficial action indicatedRichard Wolf GmbH0
2020-03-18VAIVoluntary action indicatedRichard Wolf Medical Instruments Corp.1
2019-09-10VAIVoluntary action indicatedRichard Wolf GmbH0
2019-09-10VAIVoluntary action indicatedRichard Wolf GmbH0
2018-07-17VAIVoluntary action indicatedRichard Wolf Medical Instruments Corp.6
2014-10-10VAIVoluntary action indicatedRichard Wolf Medical Instruments Corp.8
2014-08-29NAINo action indicatedRichard Wolf GmbH0
2014-08-29NAINo action indicatedRichard Wolf GmbH0
2014-02-28WLWarning LetterRichard Wolf Medical Instruments Corp.—
2013-05-08OAIOfficial action indicatedRichard Wolf Medical Instruments Corp.5
2012-09-10VAIVoluntary action indicatedRichard Wolf Medical Instruments Corp.1
2010-06-10VAIVoluntary action indicatedRichard Wolf GmbH1
2010-06-10VAIVoluntary action indicatedRichard Wolf GmbH1
2010-03-03NAINo action indicatedRichard Wolf Medical Instruments Corp.0
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