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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
1,371
Deaths
10
Injuries
100
Malfunctions
1,249

Reports per year

11
12
13
14
15
16
17
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2011–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

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Recent recalls

No recalls listed in the FDA device recall database for this entry.

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