MAUDE manufacturer profile

ABBOTT MEDICAL. - CARDIOMEMS · MOM

MAUDE profile for System, Hemodynamic, Implantable

Key facts

Manufacturer ABBOTT MEDICAL. - CARDIOMEMS
Manufacturer group ABBOTT MEDICAL. - CARDIOMEMS
Product code MOM
Product code name System, Hemodynamic, Implantable

At a glance

  • 100–999 MAUDE reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Application Program Problem, Material Frayed, Incorrect Measurement, Inappropriate Waveform, Sparking, Adverse Event Without Identified Device or Use Problem, Failure to Power Up Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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