Eversense® Smart Transmitter Kit – Provider Purchase FG-3302-01-001Recalls & reported problems
Senseonics, Incorporated · Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card. · Class 3
All models of Eversense CGM (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817491022516), received between Mar 8, 2022 and Mar 8, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Imprecision” (1 report).
1 other recall cover devices cleared under the same FDA submission (P160048); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Imprecision1
Patient problems
- Hypoglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 8, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER PASSED OUT AND WENT TO THE EMERGENCY ROOM DUE TO LOW GLUCOSE RESULTS NOT DETECTED BY TRANSMITTER.
Patient problems: Hypoglycemia
MAUDE report 13690641 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P160048. One submission often covers many models, so check the product and lot details in each record.
- Z-0251-2020 · Sep 18, 2019 · TerminatedEversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Other Sensor, Glucose, Implanted, Non-Adjunctive Use devices
- Eversense E3 Sensor Kit - DME FG-7200-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use334 reports
- Eversense E3 Sensor Kit – Provider Purchase FG-7202-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use90 reports
- Eversense E3 Sensor Kit - Retail FG-7201-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use87 reports
- Eversense E3 Smart Transmitter Kit FG-5900-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use79 reports
- Eversense E3 Smart Transmitter Kit - Retail FG-5901-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use28 reports
- Eversense E3 Smart Transmitter Kit - Provider Purchase FG-5902-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use20 reports
- Eversense® Sensor Kit – Provider Purchase FG-4202-00-301Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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