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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
2026-04-21NAINo action indicatedBard Peripheral Vascular Inc0
2024-03-08NAINo action indicatedBard Peripheral Vascular Inc0
2018-11-02NAINo action indicatedBard Peripheral Vascular Inc0
2017-02-03NAINo action indicatedBard Peripheral Vascular Inc0
2016-11-01NAINo action indicatedBard Peripheral Vascular Inc0
2016-02-26VAIVoluntary action indicatedBard Peripheral Vascular Inc2
2015-12-18VAIVoluntary action indicatedBard Peripheral Vascular Inc0
2015-01-05OAIOfficial action indicatedBard Peripheral Vascular Inc3
2014-03-20NAINo action indicatedBard Peripheral Vascular Inc0
2014-02-24NAINo action indicatedBard Peripheral Vascular Inc0
2011-08-05NAINo action indicatedBard Peripheral Vascular Inc0
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