Eversense Sensor Kit - RetailRecalls & 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
- 37
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 2 models of Eversense Sensor Kit - Retail by Senseonics, Incorporated in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2019 and Aug 11, 2022 — classified as 12 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (18 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
Most reported Eversense Sensor Kit - Retail problems
Device problems
- Failure to Sense18
- Difficult to Remove10
- Imprecision4
- Adverse Event Without Identified Device or Use Problem3
- Device Sensing Problem2
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- No Known Impact Or Consequence To Patient10
- Discomfort9
- No Code Available3
- Post Operative Wound Infection2
- Unspecified Infection1
Eversense Sensor Kit - Retail models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Eversense® Sensor Kit - Retail FG-4201-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use34 reports
- Eversense® Sensor Kit - Retail FG-4201-00-301Continuous Glucose Monitor, Implanted, Adjunctive Use3 reports
Recent Eversense Sensor Kit - Retail adverse event reports
The 15 most recent reports across all models, 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 ↗
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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