MAUDE manufacturer profile

CARDIAC ASSIST INC. · DWF

MAUDE profile for Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Key facts

Manufacturer CARDIAC ASSIST INC.
Manufacturer group CARDIAC ASSIST INC.
Product code DWF
Product code name Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Insufficient Information, No Clinical Signs, Symptoms or Conditions, Hypovolemic Shock, Tricuspid Valve Insufficiency/ Regurgitation, Patient Device Interaction Problem, Crack, Positioning Failure, Migration 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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