Edwards Lifesciences, PR
FDA adverse event reports naming Edwards Lifesciences, PR as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: EDWARDS LIFESCIENCES, PR.
- Total reports
- 4,055
- Deaths
- 38
- Injuries
- 215
- Malfunctions
- 3,774
Reports per year
35212
25313
10014
12315
13916
14717
21718
28219
10520
17521
36522
26423
16324
18525
15726
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Catheter, Flow DirectedDYG1,282
- Catheter, EmbolectomyDXE1,126
- Catheter, Oximeter, Fiber-OpticDQE563
- Electrode, Pacemaker, TemporaryLDF437
- Introducer, CatheterDYB105
- Catheter, Intravascular, DiagnosticDQO85
- Catheter, PercutaneousDQY85
- Probe, ThermodilutionKRB79
- Catheter, Continuous FlushKRA71
- Clamp, VascularDXC69
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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