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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
2021-08-27VAIVoluntary action indicatedHobbs Medical, Inc.3
2021-08-27VAIVoluntary action indicatedHobbs Medical, Inc.3
2019-01-29NAINo action indicatedHobbs Medical, Inc.0
2019-01-29NAINo action indicatedHobbs Medical, Inc.0
2017-06-23VAIVoluntary action indicatedHobbs Medical, Inc.1
2017-06-23VAIVoluntary action indicatedHobbs Medical, Inc.1
2013-08-01NAINo action indicatedHobbs Medical, Inc.0
2013-08-01NAINo action indicatedHobbs Medical, Inc.0
2011-01-06NAINo action indicatedHobbs Medical, Inc.0
2011-01-06NAINo action indicatedHobbs Medical, Inc.0
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