MAUDE manufacturer profile

FOGARTY ARTERIAL EMBOLECTOMY CATHETER · DXE

MAUDE profile for Catheter, Embolectomy

Key facts

Manufacturer FOGARTY ARTERIAL EMBOLECTOMY CATHETER
Manufacturer group EDWARDS LIFESCIENCES PR
Product code DXE
Product code name Catheter, Embolectomy

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Material Puncture/Hole, No Clinical Signs, Symptoms or Conditions 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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