Eversense® Sensor Kit - Retail FG-4201-00-301 (UDI 00817491022356)Recalls & reported problems
Senseonics, Incorporated · Eversense Sensor Kit contains one Eversense Sensor. · Class 3 · Implant
All models of Eversense CGM (20) · Eversense Sensor Kit - Retail (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Eversense sensor kit is an implanted continuous glucose monitor sensor placed under the skin to track glucose levels. The reports mostly describe the sensor not picking up readings properly, giving inaccurate numbers, and being hard or impossible to remove from the arm, sometimes breaking during removal. There are 34 adverse event reports, with 11 injuries and 23 malfunctions, and no deaths. 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
- 34
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00817491022356), received between Aug 30, 2019 and Aug 11, 2022 — classified as 11 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (18 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 Sense18
- Difficult to Remove7
- Imprecision4
- Adverse Event Without Identified Device or Use Problem3
- Device Sensing Problem2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Discomfort8
- No Known Impact Or Consequence To Patient8
- No Code Available3
- Post Operative Wound Infection2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
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 15210430 ↗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 15210268 ↗MalfunctionApr 12, 2022Failure to Sense; Failure to Sense
ON (B)(6) 2022, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER WAS NOT ABLE TO SUCCESSFULLY LINK SENSOR TO TRANSMITTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14084176 ↗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 13486079 ↗MalfunctionDec 23, 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 13079435 ↗MalfunctionDec 23, 2021Device Sensing Problem; Device Sensing Problem
ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED NO SENSOR DETECTED ALERT LEADING TO EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13078827 ↗MalfunctionDec 23, 2021Imprecision; Imprecision
ON (B)(6) 2021,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED INACCURACIES IN SENSOR READINGS LEADING TO EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13078072 ↗MalfunctionDec 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 12974160 ↗MalfunctionDec 8, 2021Failure to Sense; Failure to Sense
ON 09TH 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 12965791 ↗MalfunctionDec 6, 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 12945813 ↗MalfunctionDec 6, 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 12944843 ↗MalfunctionDec 4, 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 12930944 ↗InjuryJul 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON JUNE 29TH 2021, SENSEONICS WAS MADE AWARE OF AN ADVERESE EVENT WHERE A HORRIBLE INFECTION HAS BEEN DEVELOPED IN PATIENT'S ARM WHERE THE SENSOR WAS REMOVED FROM AND PATIENT WAS ADMITTED IN EMERGENCY ROOM.
Patient problems: Unspecified Infection
MAUDE report 12243681 ↗MalfunctionJan 25, 2021Imprecision; Imprecision
ON (B)(6) 2020,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 11227473 ↗MalfunctionOct 30, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2020, 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 10765597 ↗InjuryOct 29, 2020Difficult to Remove; Difficult to Remove
ON SEPTEMBER 29TH 2020, 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 10759782 ↗InjuryOct 29, 2020Difficult to Remove; Difficult to Remove
ON (B)(6) 2020, 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 10758067 ↗MalfunctionOct 4, 2020Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem
ON SEPT 04TH 2020,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED A "NEW SENSOR DETECTED" ALERT WHEN PREPARING THE USER WHILE TROUBLESHOOTING A DIIFERENT CASE OF "NO SENSOR DETECTED" ALERT. IT WAS CONFIRMED THAT THE TRANSMITTER IS DETECTING BOTH THE PREVIOUS SENSOR AND THE NEW ONE, PREVENTING THE SYSTEM FROM WORKING PROPERLY, RESULTING IN SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10624511 ↗InjurySep 30, 2020Difficult to Remove; Difficult to Remove
ON AUGUST 31ST 2020, SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR IN THE FIRST ATTEMPT MADE.
Patient problems: Discomfort
MAUDE report 10609808 ↗MalfunctionSep 22, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2020, 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 10567805 ↗MalfunctionAug 11, 2020Failure to Sense; Failure to Sense
ON JULY 13TH 2020, 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; No Known Impact Or Consequence To Patient
MAUDE report 10391757 ↗MalfunctionAug 3, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2020,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; No Known Impact Or Consequence To Patient
MAUDE report 10356584 ↗MalfunctionMay 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2020, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10052395 ↗InjuryApr 1, 2020Difficult to Remove; Difficult to Remove
ON (B)(6) 2020, 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 9911355 ↗MalfunctionMar 3, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2020,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 9779977 ↗
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® Sensor Kit FG-4200-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use742 reports
- 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® 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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