Edwards Lifesciences DR
FDA adverse event reports naming Edwards Lifesciences DR as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: EDWARDS LIFESCIENCES DR.
- Total reports
- 1,996
- Deaths
- 8
- Injuries
- 84
- Malfunctions
- 1,897
Reports per year
8112
10413
6714
8615
10816
10317
12818
9519
7520
10721
8722
12523
17724
24225
15026
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
- Transducer, Pressure, Catheter TipDXO1,228
- Transducer, Blood-Pressure, ExtravascularDRS297
- System, Measurement, Blood-Pressure, Non-InvasiveDXN154
- Catheter, Continuous FlushKRA76
- Catheter, Flow DirectedDYG75
- Arterial Blood Sampling KitCBT74
- Probe, ThermodilutionKRB21
- Computer, Diagnostic, ProgrammableDQK16
- Adjunctive Predictive Cardiovascular IndicatorQAQ12
- Catheter, EmbolectomyDXE9
Recent recalls
No recalls listed in the FDA device recall database for this entry.
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