Eversense® Sensor Kit – Provider Purchase FG-4202-00-301Recalls & reported problems
Senseonics, Incorporated · Eversense Sensor Kit contains one Eversense Sensor. · Class 3 · Implant
All models of Eversense CGM (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00817491022523), received between May 10, 2021 and Jun 29, 2022 — classified as 4 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (7 reports).
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
- Failure to Sense7
- Difficult to Remove3
- Imprecision3
- Device Sensing Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Discomfort3
- Hypoglycemia1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 29, 2022Failure to Sense; Failure to Sense
ON 29 MAY 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING INNAN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14854421 ↗InjuryJun 9, 2022Difficult to Remove; Difficult to Remove
ON 13 MAY 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR FROM THE USERS ARM.
Patient problems: Discomfort
MAUDE report 14644244 ↗MalfunctionMay 3, 2022Failure to Sense; Failure to Sense
ON 04 FEBRUARY 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14269045 ↗MalfunctionMar 31, 2022Device Sensing Problem; Device Sensing Problem
ON (B)(6)2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED NO SENSOR DETECTED ALERT LEADING TO EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13972078 ↗MalfunctionMar 23, 2022Failure to Sense; Failure to Sense
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13866726 ↗InjuryFeb 23, 2022Imprecision; Imprecision
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED LOW GLUCOSE SYMPTOMS AND HAD TO GO TO THE EMERGENCY ROOM.
Patient problems: Hypoglycemia
MAUDE report 13586641 ↗InjuryFeb 8, 2022Difficult to Remove; Difficult to Remove
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE.
Patient problems: Discomfort
MAUDE report 13485993 ↗MalfunctionFeb 4, 2022Failure to Sense; Failure to Sense
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13459678 ↗InjuryFeb 2, 2022Difficult to Remove; Difficult to Remove
ON JANUARY 17TH 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR FROM THE USERS LEFT ARM ON THE FIRST ATTEMPT.
Patient problems: Discomfort
MAUDE report 13423028 ↗MalfunctionJan 25, 2022Failure to Sense; Failure to Sense
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13353198 ↗MalfunctionDec 22, 2021Imprecision; Imprecision
ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED INACCURACIES IN SENSOR READINGS WHICH LEADS TO EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13062000 ↗MalfunctionDec 21, 2021Imprecision; Imprecision
ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED INACCURACIES IN SENSOR READINGS WHICH LEADS TO EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13056140 ↗MalfunctionDec 21, 2021Device Sensing Problem; Device Sensing Problem
ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED NO SENSOR DETECTED ALERT LEADING TO EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13055207 ↗MalfunctionNov 23, 2021Failure to Sense; Failure to Sense
ON OCTOBER 24TH 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12866711 ↗MalfunctionMay 10, 2021Failure to Sense; Failure to Sense
ON (B)(6) 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11803823 ↗
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® Smart Transmitter Kit – Provider Purchase FG-3302-01-001Senseonics, Incorporated · Sensor, Glucose, Implanted, Non-Adjunctive Use1 report
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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