Senseonics Inc.

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

Total reports: 6,260
Deaths: 0
Injuries: 2,651
Malfunctions: 3,609

Reports per year

Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone AcetateSBA2,768
Sensor, Glucose, Implanted, Non-Adjunctive UseQHJ2,271
Continuous Glucose Monitor, Implanted, Adjunctive UseQCD1,220
Integrated Continuous Glucose Monitoring System, Factory CalibratedQBJ1

Recent recalls

TerminatedProcess control
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

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