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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
2018-05-14VAIVoluntary action indicatedSummit Medical, LLC6
2018-05-14VAIVoluntary action indicatedSummit Medical, LLC6
2018-03-09VAIVoluntary action indicatedSummit Medical, LLC3
2018-03-09VAIVoluntary action indicatedSummit Medical, LLC3
2018-03-05NAINo action indicatedSummit International Medical Technologies, Inc.0
2016-11-10VAIVoluntary action indicatedSummit Medical, LLC5
2016-11-10VAIVoluntary action indicatedSummit Medical, LLC5
2015-08-05VAIVoluntary action indicatedSummit Medical Ltd.2
2015-08-05VAIVoluntary action indicatedSummit Medical Ltd.2
2015-03-04NAINo action indicatedSummit Medical, LLC0
2015-03-04NAINo action indicatedSummit Medical, LLC0
2014-05-05VAIVoluntary action indicatedSummit Medical, LLC3
2014-05-05VAIVoluntary action indicatedSummit Medical, LLC3
2013-04-25WLWarning LetterSummit Medical, LLC—
2013-04-25WLWarning LetterSummit Medical, LLC—
2013-01-28OAIOfficial action indicatedSummit Medical, LLC11
2013-01-28OAIOfficial action indicatedSummit Medical, LLC11
2012-09-07NAINo action indicatedSummit Medical, LLC2
2012-09-07NAINo action indicatedSummit Medical, LLC2
2010-12-02NAINo action indicatedSummit Medical Ltd.0
2010-12-02NAINo action indicatedSummit Medical Ltd.0
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