PlainHospital

EDWARDS LIFESCIENCES, PR

Manufacturer adverse-event records for EDWARDS LIFESCIENCES, PR 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 · 2008–2026 · thin-book · elevated Death-code · injury-light

Volume signature

EDWARDS LIFESCIENCES, PR is a thinner MAUDE footprint

EDWARDS LIFESCIENCES, PR accounts for 3,922 FDA MAUDE reports (#413 of 443, thin-book tercile). Death-coded event_type share is 0.97% (elevated); Injury share 5.4% (injury-light).

What the volume reading shows for EDWARDS LIFESCIENCES, PR

The standout signal for EDWARDS LIFESCIENCES, PR is filing volume: 3,922 adverse-event reports in FDA MAUDE (#413 of 443, thin-book). Death-coded event_type share sits at 0.97% (elevated).

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 Malfunction at 3,646 (93.0% of event_type total). Peak single-year volume reaches 365 reports across 19 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

3,922
Total Reports
38
Event-type Death
210
Injury Reports
20
Device Types

Event Types

Malfunction 3,646 (93.0%)
Injury 210 (5.4%)
Death 38 (1.0%)
Other 23 (0.6%)
5 (0.1%)

Patient Outcomes

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

3,371 (85.4%)
Other 388 (9.8%)
Required Intervention 72 (1.8%)
Death 44 (1.1%)
Hospitalization 20 (0.5%)
R 19 (0.5%)
Life Threatening 19 (0.5%)
O 8 (0.2%)
L 4 (0.1%)
H 3 (0.1%)

Devices (20)

Device Reports
Catheter, Flow Directed 1,236
Catheter, Embolectomy 1,071
Catheter, Oximeter, Fiber-Optic 561
Electrode, Pacemaker, Temporary 436
Introducer, Catheter 105
Catheter, Percutaneous 85
Catheter, Intravascular, Diagnostic 81
Probe, Thermodilution 79
Catheter, Continuous Flush 71
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days 51
Clamp, Vascular 47
Catheter, Intravascular Occluding, Temporary 22
Catheter, Septostomy 19
Permanent Pacemaker Electrode 16
Transducer, Blood-Pressure, Extravascular 11
Catheter, Peripheral, Atherectomy 8
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection 4
Computer, Diagnostic, Pre-Programmed, Single-Function 4
Catheter, Cholangiography 3
Catheter, Irrigation 2

Yearly Trend

08
2008: 319
09
2009: 191
10
2010: 186
11
2011: 332
12
2012: 352
13
2013: 253
14
2014: 100
15
2015: 123
16
2016: 139
17
2017: 147
18
2018: 217
19
2019: 282
20
2020: 105
21
2021: 175
22
2022: 365
23
2023: 264
24
2024: 163
25
2025: 185
26
2026: 24

Read our methodology - how this data is sourced, computed, and verified.