MAUDE brand profile

FARAWAVE PULSED FIELD ABLATION CATHETER 31MM

MAUDE brand safety profile

Key facts

Brand name FARAWAVE PULSED FIELD ABLATION CATHETER 31MM

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 100–999 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Entrapment of Device, Off-Label Use, Detachment of Device or Device Component, Improper Flow or Infusion, Pericardial Effusion, Material Twisted/Bent Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE brand safety profiles

Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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