EDWARDS LIFESCIENCES LLC

Manufacturer adverse-event records for EDWARDS LIFESCIENCES LLC 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 · 2002–2026 · thin-book · elevated Death-code · injury-heavy

Death-code intensity

EDWARDS LIFESCIENCES LLC carries an elevated Death-code share

Death-coded event_type rows are 1,228 of 6,667 (18.42% · elevated tercile among 443 manufacturers). Absolute volume is thin-book.

What the Death-code reading shows for EDWARDS LIFESCIENCES LLC

The standout signal for EDWARDS LIFESCIENCES LLC is Death-code intensity: 18.42% of 6,667 reports (elevated tercile), while absolute volume is thin-book.

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Injury at 4,668 (70.0% of event_type total). Peak single-year volume reaches 1,987 reports across 24 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

6,667
Total Reports
1,228
Event-type Death
4,668
Injury Reports
20
Device Types

Event Types

Injury 4,668 (70.0%)
Death 1,228 (18.4%)
Malfunction 762 (11.4%)
6 (0.1%)
Other 3 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 1,907 (20.6%)
Other 1,686 (18.2%)
Death 1,199 (12.9%)
R 891 (9.6%)
L 861 (9.3%)
806 (8.7%)
H 715 (7.7%)
Hospitalization 583 (6.3%)
Life Threatening 399 (4.3%)
O 87 (0.9%)
Disability 74 (0.8%)
D 45 (0.5%)
S 13 (0.1%)
C 3 (0.0%)
Congenital Anomaly 2 (0.0%)

Yearly Trend

02
2002: 6
03
2003: 5
04
2004: 10
05
2005: 14
07
2007: 15
08
2008: 3
09
2009: 9
10
2010: 6
11
2011: 9
12
2012: 13
13
2013: 6
14
2014: 7
15
2015: 7
16
2016: 14
17
2017: 40
18
2018: 45
19
2019: 42
20
2020: 98
21
2021: 450
22
2022: 747
23
2023: 1,094
24
2024: 1,987
25
2025: 1,905
26
2026: 135