Eversense® Sensor Kit FG-4200-00-301 (UDI 00817491022349)Recalls & reported problems
Senseonics, Incorporated · Eversense Sensor Kit contains one Eversense Sensor. · Class 3 · Implant
All models of Eversense CGM (20) · Eversense Sensor Kit (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Eversense implanted glucose sensor is placed under the skin to measure glucose continuously. Its 742 reports mostly describe the sensor not picking up glucose readings, and some describe it being hard to remove, with failed removal attempts and infection at the insertion site. The reports include no deaths and 307 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 742
- Deaths reported
- 0
- Injuries reported
- 307
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 742 adverse event reports that list this exact device (DI 00817491022349), received between Apr 30, 2019 and May 24, 2025 — classified as 307 injuries, 435 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (329 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Sense329
- Difficult to Remove172
- Adverse Event Without Identified Device or Use Problem99
- Imprecision61
- Device Sensing Problem33
- Material Separation29
- Connection Problem6
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Discomfort225
- No Clinical Signs, Symptoms or Conditions201
- No Known Impact Or Consequence To Patient160
- No Code Available157
- Unspecified Infection24
- Pain20
- Post Operative Wound Infection17
- No Information7
Recent adverse event reports
The 25 most recent of 742 reports, 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 ↗InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 28 JULY 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT THE INSERTION SITE WAS INFECTED DUE TO INSERTION.
Patient problems: Unspecified Infection
MAUDE report 15249266 ↗InjuryAug 11, 2022Material Separation; Material Separation
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USERS SENSOR BROKE DURING THE REMOVAL PROCEDURE.
Patient problems: Discomfort
MAUDE report 15214474 ↗InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 12 JULY 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED DISCOMFORT AND PAIN NEAR INSERTION SITE THAT RESULTED IN SENSOR REMOVAL.
Patient problems: Discomfort
MAUDE report 15212436 ↗InjuryAug 11, 2022Difficult to Remove; Difficult to Remove
ON 13 JULY 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 15210311 ↗InjuryAug 4, 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 FROM THE USERS ARM.
Patient problems: Discomfort
MAUDE report 15165819 ↗InjuryAug 4, 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 FROM THE USERS ARM.
Patient problems: Discomfort
MAUDE report 15164037 ↗MalfunctionJul 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 A EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15084007 ↗InjuryJul 6, 2022Difficult to Remove; Difficult to Remove
ON 09 JUNE 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR FROM THE USERS ARM ON THE SECOND ATTEMPT.
Patient problems: Discomfort
MAUDE report 14924609 ↗InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON 07 JUNE 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTS HAVING TO KEEP GOING BACK INTO INITIALIZATION PHASE DUE TO HAVING TWO SENSORS IN ARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14923882 ↗InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT THAT CAUSED THE USER TO BE HOSPITALIZED.
Patient problems: Urinary Tract Infection
MAUDE report 14923766 ↗
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 Continuous Glucose Monitor, Implanted, Adjunctive Use devices
- Eversense® Smart Transmitter Kit FG-3300-01-001Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use208 reports
- Eversense® Sensor Kit FG-4200-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use82 reports
- Eversense® Sensor Kit - Retail FG-4201-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use34 reports
- Eversense® Smart Transmsitter Kit - Retail FG-3301-01-001Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use8 reports
- Eversense® Sensor Kit - Retail FG-4201-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use3 reports
- Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear FG-6403-01-300Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page