MAUDE manufacturer profile

MEDTRONIC HEART VALVES DIVISION · DWS

MAUDE profile for Instruments, Surgical, Cardiovascular

Key facts

Manufacturer MEDTRONIC HEART VALVES DIVISION
Manufacturer group MEDTRONIC HEART VALVES DIVISION
Product code DWS
Product code name Instruments, Surgical, Cardiovascular

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Insufficient Information, Physical Resistance/Sticking, Device Operates Differently Than Expected, Vascular Dissection, No Information, No Known Impact Or Consequence To Patient, Packaging Problem 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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