EDWARDS LIFESCIENCES
Manufacturer adverse-event records for EDWARDS LIFESCIENCES come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 2000–2026 · heavy-book · elevated Death-code · injury-heavy
Death-code intensity
EDWARDS LIFESCIENCES carries an elevated Death-code share
Death-coded event_type rows are 5,941 of 83,068 (7.15% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.
What the Death-code reading shows for EDWARDS LIFESCIENCES
The standout signal for EDWARDS LIFESCIENCES is Death-code intensity: 7.15% of 83,068 reports (elevated tercile), while absolute volume is heavy-book.
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair EDWARDS LIFESCIENCES with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.
Reports span 20 device types, led in this extract by Injury at 65,518 (78.9% of event_type total). Peak single-year volume reaches 7,932 reports across 27 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (20)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.