MAUDE brand profile

HEARTWARE VENTRICULAR ASSIST DEV HVAD

MAUDE brand safety profile

Key facts

Brand name HEARTWARE VENTRICULAR ASSIST DEV HVAD

At a glance

  • 10–99 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems coded
  • 1–9 Problems flagged by Orca1 signal analytics
  • Failure to Power Up, Device Alarm System, Battery Problem, No Clinical Signs, Symptoms or Conditions, Pumping Stopped, Failure of Implant, Protective Measures Problem, Activation Failure Most reported problems

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

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

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

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