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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
2016-03-16NAINo action indicatedRiverpoint Medical, LLC0
2016-03-16NAINo action indicatedRiverpoint Medical, LLC0
2013-12-02VAIVoluntary action indicatedRiverpoint Medical, LLC1
2013-12-02VAIVoluntary action indicatedRiverpoint Medical, LLC1
2013-05-01WLWarning LetterRiverpoint Medical, LLC—
2013-05-01WLWarning LetterRiverpoint Medical, LLC—
2013-02-04OAIOfficial action indicatedRiverpoint Medical, LLC8
2013-02-04OAIOfficial action indicatedRiverpoint Medical, LLC8
2011-08-04NAINo action indicatedRiverpoint Medical, LLC0
2011-08-04NAINo action indicatedRiverpoint Medical, LLC0
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