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 6,419 of 87,709 (7.32% · elevated tercile among 434 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: 7.32% of 87,709 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 69,173 (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.

87,709
Total Reports
6,419
Event-type Death
69,173
Injury Reports
20
Device Types

Event Types

Injury 69,173 (78.9%)
Malfunction 11,316 (12.9%)
Death 6,419 (7.3%)
Other 621 (0.7%)
180 (0.2%)

Patient Outcomes

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

Required Intervention 43,241 (33.1%)
R 23,900 (18.3%)
Hospitalization 18,827 (14.4%)
L 10,544 (8.1%)
10,445 (8.0%)
H 8,022 (6.1%)
Death 6,200 (4.7%)
Life Threatening 4,236 (3.2%)
Other 3,573 (2.7%)
O 801 (0.6%)
D 485 (0.4%)
Disability 299 (0.2%)
S 151 (0.1%)
Congenital Anomaly 16 (0.0%)
C 5 (0.0%)

Yearly Trend

00
2000: 1
01
2001: 361
02
2002: 503
03
2003: 348
04
2004: 476
05
2005: 666
06
2006: 697
07
2007: 1,369
08
2008: 3,275
09
2009: 2,637
10
2010: 2,048
11
2011: 1,781
12
2012: 2,066
13
2013: 2,829
14
2014: 3,023
15
2015: 3,338
16
2016: 3,547
17
2017: 4,197
18
2018: 5,231
19
2019: 4,629
20
2020: 5,070
21
2021: 5,564
22
2022: 5,858
23
2023: 7,228
24
2024: 7,268
25
2025: 7,932
26
2026: 5,767