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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
2024-04-18NAINo action indicatedPhysio-Control, Inc.0
2019-11-26VAIVoluntary action indicatedPhysio-Control, Inc.4
2019-03-29NAINo action indicatedPhysio-Control, Inc.0
2017-12-15VAIVoluntary action indicatedPhysio-Control, Inc.2
2016-11-18VAIVoluntary action indicatedPhysio-Control, Inc.6
2015-06-26OAIOfficial action indicatedPhysio-Control, Inc.1
2014-01-17VAIVoluntary action indicatedPhysio-Control, Inc.3
2013-11-26INJInjunctionPhysio-Control, Inc.—
2012-10-24VAIVoluntary action indicatedPhysio-Control, Inc.3
2012-10-24NAINo action indicatedPhysio-Control, Inc.0
2010-01-05VAIVoluntary action indicatedPhysio-Control, Inc.1
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