Eversense CGMRecalls & reported problems across all models
Senseonics, Incorporated · 20 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,148
- Deaths reported
- 0
- Injuries reported
- 1,417
- Recalls
- 0
We found 20 models of Eversense CGM by Senseonics, Incorporated in the FDA's device registry (GUDID). Together they are named in 4,148 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2018 and Sep 30, 2026 — classified as 1,417 injuries, 2,731 malfunctions.
The most frequently reported specific device problem is “Imprecision” (2,111 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Eversense CGM problems
Device problems
- Imprecision2,111
- Failure to Sense588
- Adverse Event Without Identified Device or Use Problem569
- Difficult to Remove336
- Output Problem171
- Communication or Transmission Problem109
- Premature End-of-Life Indicator82
- Material Separation73
Patient problems
- No Clinical Signs, Symptoms or Conditions2,581
- Discomfort389
- Hypoglycemia313
- No Known Impact Or Consequence To Patient226
- No Code Available168
- Hyperglycemia148
- Skin Infection89
- Unspecified Infection72
Eversense CGM models
20 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Eversense 365 Sensor Kit (DME) FG-7500-00-301Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate1,915 reports
- Eversense® Sensor Kit FG-4200-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use742 reports
- Eversense E3 Sensor Kit - DME FG-7200-00-301Sensor, Glucose, Implanted, Non-Adjunctive Use334 reports
- Eversense 365 Sensor Kit (Provider Purchase) FG-7502-00-301Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate297 reports
- Eversense® Smart Transmitter Kit FG-3300-01-001Continuous Glucose Monitor, Implanted, Adjunctive Use208 reports
- Eversense 365 Sensor Kit (Retail) FG-7501-00-301Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate171 reports
- Eversense E3 Sensor Kit – Provider Purchase FG-7202-00-301Sensor, Glucose, Implanted, Non-Adjunctive Use90 reports
- Eversense E3 Sensor Kit - Retail FG-7201-00-301Sensor, Glucose, Implanted, Non-Adjunctive Use87 reports
- Eversense® Sensor Kit FG-4200-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use82 reports
- Eversense E3 Smart Transmitter Kit FG-5900-01-001Sensor, Glucose, Implanted, Non-Adjunctive Use79 reports
- Eversense® Sensor Kit - Retail FG-4201-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use34 reports
- Eversense 365 Smart Transmitter Kit (DME) FG-4000-01-001Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate29 reports
- Eversense E3 Smart Transmitter Kit - Retail FG-5901-01-001Sensor, Glucose, Implanted, Non-Adjunctive Use28 reports
- Eversense E3 Smart Transmitter Kit - Provider Purchase FG-5902-01-001Sensor, Glucose, Implanted, Non-Adjunctive Use20 reports
- Eversense® Sensor Kit – Provider Purchase FG-4202-00-301Sensor, Glucose, Implanted, Non-Adjunctive Use15 reports
- Eversense® Smart Transmsitter Kit - Retail FG-3301-01-001Continuous Glucose Monitor, Implanted, Adjunctive Use8 reports
- Eversense 365 Smart Transmitter Kit (Retail) FG-4001-01-001Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate4 reports
- Eversense® Sensor Kit - Retail FG-4201-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use3 reports
- Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear FG-6403-01-300Continuous Glucose Monitor, Implanted, Adjunctive Use1 report
- Eversense® Smart Transmitter Kit – Provider Purchase FG-3302-01-001Sensor, Glucose, Implanted, Non-Adjunctive Use1 report
Recent Eversense CGM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952853 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938641 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938640 ↗MalfunctionSep 29, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938639 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938638 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938637 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938636 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938635 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938634 ↗MalfunctionSep 29, 2026Imprecision
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938633 ↗MalfunctionSep 29, 2026Imprecision
Senseonics was made aware of an incident where user reported an event where the CGM showed results that are different from blood glucometer measurements. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927138 ↗MalfunctionSep 29, 2026Output Problem
On (b)(6) 2026, Senseonics was made aware of an incident where user received a glucose suspend alert which resulted in an early sensor removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927137 ↗MalfunctionSep 29, 2026Imprecision
Senseonics was made aware of an incident where user reported an event where the CGM showed results that are different from blood glucometer measurements. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927136 ↗MalfunctionSep 29, 2026Output Problem
On (b)(6) 2026, Senseonics was made aware of an incident where user received a glucose suspend alert which resulted in an early sensor removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927135 ↗MalfunctionSep 29, 2026Imprecision
Senseonics was made aware of an incident where user reported an event where the CGM showed results that are different from blood glucometer measurements. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927134 ↗
Other Senseonics, Incorporated products
All Senseonics, Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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