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
- 1,355
- Deaths
- 10
- Injuries
- 87
- Malfunctions
- 1,246
Reports per year
411
212
3013
12114
12815
12816
10017
119
11320
4021
8422
8523
16824
13825
10226
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
No recalls listed in the FDA device recall database for this entry.
Monitor Edwards Lifesciences PR automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.