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Therasense, Inc.

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

Total reports
1,164
Deaths
1
Injuries
578
Malfunctions
577

Reports per year

01
02
03
04
05
06

Source: FDA adverse event reports by year received, 20012006. 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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