Eversense Sensor KitRecalls & reported problems across all models
Senseonics, Incorporated · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 824
- Deaths reported
- 0
- Injuries reported
- 335
- Recalls
- 0
We found 2 models of Eversense Sensor Kit by Senseonics, Incorporated in the FDA's device registry (GUDID). Together they are named in 824 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2018 and May 24, 2025 — classified as 335 injuries, 489 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (374 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 Sensor Kit problems
Device problems
- Failure to Sense374
- Difficult to Remove189
- Adverse Event Without Identified Device or Use Problem109
- Imprecision67
- Device Sensing Problem33
- Material Separation31
- Connection Problem6
- Communication or Transmission Problem4
Patient problems
- Discomfort236
- No Known Impact Or Consequence To Patient213
- No Clinical Signs, Symptoms or Conditions201
- No Code Available163
- Post Operative Wound Infection24
- Unspecified Infection24
- Pain21
- No Consequences Or Impact To Patient7
Eversense Sensor Kit models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Eversense® Sensor Kit FG-4200-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use742 reports
- Eversense® Sensor Kit FG-4200-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use82 reports
Recent Eversense Sensor Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMay 24, 2025Difficult to Remove; Difficult to Remove
ON 24 APRIL 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE HCP WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22082158 ↗InjuryMar 27, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem
ON FEBRUARY 26, 2024, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE REGIONAL CLINICAL MANAGER REPORTED THAT THE USER EXPERIENCED A FAILED REMOVAL ATTEMPT ON 14 OCTOBER 2023.
Patient problems: Discomfort
MAUDE report 18989857 ↗InjuryMar 14, 2024Difficult to Remove; Difficult to Remove
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER'S SENSOR COULD NOT BE REMOVED ON THE FIRST REMOVAL ATTEMPT.
Patient problems: Discomfort
MAUDE report 18909196 ↗InjuryMar 5, 2024Difficult to Remove; Difficult to Remove
ON 07 FEB 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR FOR TWO ATTEMPTS.HOWEVER,THE SENSOR WAS SUCCESSFULLY REMOVED ON THE THIRD REMOVAL ATTEMPT.
Patient problems: Discomfort
MAUDE report 18841257 ↗InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER REPORTED AN INFECTION AT INSERTION SITE.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 18754821 ↗InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2024, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER REPORTED AN INFECTION AT INSERTION SITE.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 18754819 ↗InjuryJan 5, 2024Difficult to Remove; Difficult to Remove
ON DECEMBER 8, 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER EXPERIENCED A FAILED SENSOR REMOVAL ATTEMPT.
Patient problems: Discomfort
MAUDE report 18460443 ↗InjuryNov 8, 2023Difficult to Remove; Difficult to Remove
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER REPORTED A FAILED REMOVAL ATTEMPT BY THE HCP.
Patient problems: Discomfort
MAUDE report 18097809 ↗InjuryMay 15, 2023Material Separation; Material Separation
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE HCP(HEALTH CARE PROFESSIONAL) HAD SOME TROUBLE WHILE REMOVING THE SENSOR. HOWEVER,THE SENSOR WAS REMOVED SUCCESSFULLY ON (B)(6) 2023 BUT IT WAS OBSERVED BY THE HCP THAT SENSOR COLLAR WAS MISSING.
Patient problems: Discomfort
MAUDE report 16931657 ↗InjuryFeb 1, 2023Difficult to Remove; Difficult to Remove
ON (B)(6) 2023, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE OLD SENSOR ON THE FIRST ATTEMPT MADE.
Patient problems: Discomfort
MAUDE report 16280736 ↗InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON AUGUST 25TH 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER WENT TO THE HOSPITAL WITH ABDOMINAL PAIN, AND HAD EMERGENCY HERNIA SURGERY AND WAS ADMITTED TO HOSPITAL FOR ABOUT A WEEK.
Patient problems: Abdominal Pain; Hernia
MAUDE report 15481743 ↗InjurySep 18, 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 15443558 ↗MalfunctionAug 26, 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 15306117 ↗MalfunctionAug 22, 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 EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15270406 ↗MalfunctionAug 19, 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 A EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15260847 ↗
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.
- 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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