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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
2026-06-05VAIVoluntary action indicatedC.R. Bard Inc.2
2026-06-05VAIVoluntary action indicatedC.R. Bard Inc.2
2026-04-21NAINo action indicatedBard Peripheral Vascular Inc0
2024-11-12NAINo action indicatedC.R. Bard Inc0
2024-11-12NAINo action indicatedC.R. Bard Inc0
2024-08-23NAINo action indicatedDymax Corp0
2024-03-08NAINo action indicatedBard Peripheral Vascular Inc0
2023-08-18VAIVoluntary action indicatedBard Shannon Limited3
2022-12-07NAINo action indicatedDavol, Inc.0
2022-05-24NAINo action indicatedDavol Inc.0
2022-04-11NAINo action indicatedBard Access Systems, Inc.0
2022-02-25NAINo action indicatedVenclose, Inc.0
2021-10-27NAINo action indicatedBard Access Systems, Inc.0
2021-08-19NAINo action indicatedC.R. Bard, Inc.0
2021-07-30VAIVoluntary action indicatedDymax Corp1
2020-01-28NAINo action indicatedC.R. Bard Inc0
2020-01-28NAINo action indicatedC.R. Bard Inc0
2019-01-31VAIVoluntary action indicatedClearstream Technologies Ltd4
2019-01-25NAINo action indicatedLutonix Inc.0
2018-11-21VAIVoluntary action indicatedBard Shannon Limited0
2015-07-13WLWarning LetterC.R. Bard Inc.—
2015-07-13WLWarning LetterC.R. Bard Inc.—
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