MAUDE manufacturer profile

MEDTRONIC IRELAND · DRA

MAUDE profile for Catheter, Steerable

Key facts

Manufacturer MEDTRONIC IRELAND
Manufacturer group MEDTRONIC IRELAND
Product code DRA
Product code name Catheter, Steerable

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Material Twisted/Bent, Gas/Air Leak, Adverse Event Without Identified Device or Use Problem, Low Blood Pressure/ Hypotension, Pericardial Effusion, Cardiac Tamponade, Material Integrity 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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