MAUDE manufacturer profile

BOSTON SCIENTIFIC CORPORATION · MCX

MAUDE profile for Catheter, Coronary, Atherectomy

Key facts

Manufacturer BOSTON SCIENTIFIC CORPORATION
Manufacturer group BOSTON SCIENTIFIC CORPORATION
Product code MCX
Product code name Catheter, Coronary, Atherectomy

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Entrapment of Device, No Consequences Or Impact To Patient, Detachment of Device or Device Component, Output Problem, Adverse Event Without Identified Device or Use Problem, Fracture, Difficult to Remove 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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