MAUDE brand profile

IMPELLA 55

MAUDE brand safety profile

Key facts

Brand name IMPELLA 55

At a glance

  • 1,000+ MAUDE reports
  • 100–999 Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems coded
  • 100–999 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Hemorrhage/Blood Loss/Bleeding, Device Sensing Problem, Patient-Device Incompatibility, Thrombosis/Thrombus, Restricted Flow rate, Hematoma 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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