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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
2023-12-08NAINo action indicatedAbbott Vascular0
2023-11-16OAIOfficial action indicatedAbbott Vascular0
2023-10-27NAINo action indicatedAbbott Vascular Inc0
2022-08-23NAINo action indicatedAbbott Vascular Inc0
2021-11-03NAINo action indicatedAbbott Vascular Inc0
2019-10-24NAINo action indicatedAbbott Vascular0
2017-11-15VAIVoluntary action indicatedAbbott Vascular2
2017-10-10NAINo action indicatedAbbott Vascular0
2017-10-04NAINo action indicatedAbbott Vascular Inc0
2016-12-09NAINo action indicatedAbbott Vascular0
2016-04-15NAINo action indicatedAbbott Vascular Inc0
2015-12-10NAINo action indicatedAbbott Vascular0
2015-09-11NAINo action indicatedAbbott Vascular0
2015-08-14NAINo action indicatedAbbott Vascular, Inc.0
2015-07-23NAINo action indicatedAbbott Vascular0
2014-11-24NAINo action indicatedAbbott Vascular Inc0
2014-08-21NAINo action indicatedAbbott Vascular0
2014-03-14NAINo action indicatedAbbott Vascular0
2014-02-19NAINo action indicatedAbbott Vascular0
2014-02-11VAIVoluntary action indicatedAbbott Vascular Inc3
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