MAUDE manufacturer profile

ST. JUDE MEDICAL · MLV

MAUDE profile for Transcatheter Septal Occluder

Key facts

Manufacturer ST. JUDE MEDICAL
Manufacturer group ST. JUDE MEDICAL
Product code MLV
Product code name Transcatheter Septal Occluder

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
  • No Clinical Signs, Symptoms or Conditions, Material Deformation, Adverse Event Without Identified Device or Use Problem, Migration or Expulsion of Device, Difficult to Fold, Unfold or Collapse, Insufficient Information, Atrial Fibrillation, Inadequacy of Device Shape and/or Size 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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