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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
2024-10-30VAIVoluntary action indicatedAllied Medical LLC5
2024-10-30VAIVoluntary action indicatedAllied Medical LLC5
2023-11-08VAIVoluntary action indicatedAllied Medical LLC7
2023-11-08VAIVoluntary action indicatedAllied Medical LLC7
2016-06-28NAINo action indicatedAllied Medical LLC0
2016-06-28NAINo action indicatedAllied Medical LLC0
2015-07-06VAIVoluntary action indicatedAllied Medical LLC1
2015-07-06VAIVoluntary action indicatedAllied Medical LLC1
2013-12-11VAIVoluntary action indicatedAllied Healthcare Products, Inc.2
2013-09-10VAIVoluntary action indicatedAllied Medical LLC2
2013-09-10VAIVoluntary action indicatedAllied Medical LLC2
2012-07-11NAINo action indicatedAllied Medical LLC0
2012-07-11NAINo action indicatedAllied Medical LLC0
2010-02-01NAINo action indicatedAllied Medical LLC0
2010-02-01NAINo action indicatedAllied Medical LLC0
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