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Farapulse, Inc.

FDA adverse event reports naming Farapulse, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: FARAPULSE, INC..

Total reports
1,357
Deaths
5
Injuries
240
Malfunctions
1,112

Reports per year

24
25
26

Source: FDA adverse event reports by year received, 20242026. 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.

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