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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
2024-09-20NAINo action indicatedB. BRAUN DOMINICAN REPUBLIC INC.0
2023-10-13NAINo action indicatedB. Braun US Pharmaceutical Manufacturing, LLC0
2018-06-01NAINo action indicatedB. Braun Medical, Inc.0
2018-06-01NAINo action indicatedB. Braun Medical, Inc.0
2018-02-22NAINo action indicatedB. BRAUN DOMINICAN REPUBLIC INC.0
2016-08-26VAIVoluntary action indicatedB. Braun Medical, Inc.2
2016-08-26VAIVoluntary action indicatedB. Braun Medical, Inc.2
2014-06-03NAINo action indicatedB. BRAUN MEDICAL AG0
2013-01-10NAINo action indicatedB. BRAUN DOMINICAN REPUBLIC INC.0
2012-12-13VAIVoluntary action indicatedB. Braun Medical, Inc.0
2012-12-13VAIVoluntary action indicatedB. Braun Medical, Inc.0
2012-08-16OAIOfficial action indicatedB Braun Medical, Inc.6
2011-03-21NAINo action indicatedB. Braun US Pharmaceutical Manufacturing, LLC0
2010-10-08OAIOfficial action indicatedB Braun Medical, Inc.5
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