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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
2021-09-17VAIVoluntary action indicated21st Century Scientific Inc5
2021-09-17VAIVoluntary action indicated21st Century Scientific Inc5
2019-05-13WLWarning Letter21st Century Scientific Inc—
2019-05-13WLWarning Letter21st Century Scientific Inc—
2018-09-12OAIOfficial action indicated21st Century Scientific Inc4
2018-09-12OAIOfficial action indicated21st Century Scientific Inc4
2017-03-21VAIVoluntary action indicated21st Century Scientific Inc5
2017-03-21VAIVoluntary action indicated21st Century Scientific Inc5
2011-07-13VAIVoluntary action indicated21st Century Scientific Inc0
2011-07-13VAIVoluntary action indicated21st Century Scientific Inc0
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