Eversense E3 Sensor Kit - Retail FG-7201-00-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00817491022967), received between Aug 4, 2022 and Dec 20, 2025 — classified as 43 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (33 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

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT IN WHICH THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR DURING THE INITIAL REMOVAL ATTEMPT. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) INDICATED THAT THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2023 AT 7:00 AM. THE USER LATER CONTACTED SENSEONICS AND REPORTED RECEIVING A CALL FROM THEIR PREVIOUS HEALTHCARE PROVIDER (HCP) TO SCHEDULE A SENSOR REMOVAL APPOINTMENT. THE USER STATED THAT THEY HAVE NOT RESIDED IN THAT STATE FOR OVER TWO YEARS AND REQUESTED ASSISTANCE IN SCHEDULING AN APPOINTMENT IN THEIR CURRENT STATE OF RESIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858378 ↗
• MalfunctionDec 20, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT IN WHICH THE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR DURING THE INITIAL REMOVAL ATTEMPT. A REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS) INDICATED THAT THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2023 AT 7:00 AM. THE USER LATER CONTACTED SENSEONICS AND REPORTED RECEIVING A CALL FROM THEIR PREVIOUS HEALTHCARE PROVIDER (HCP) TO SCHEDULE A SENSOR REMOVAL APPOINTMENT. THE USER STATED THAT THEY HAVE NOT RESIDED IN THAT STATE FOR OVER TWO YEARS AND REQUESTED ASSISTANCE IN SCHEDULING AN APPOINTMENT IN THEIR CURRENT STATE OF RESIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858377 ↗
• MalfunctionJul 12, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON JUNE 12TH, 2025, 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 22490253 ↗
• InjuryJul 11, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT PHYSICIAN WAS UNABLE TO LOCATE OR REMOVE THE EVERSENSE SENSOR DURING THE REMOVAL PROCEDURE ON (B)(6) 2025. DESPITE USING TOOLS SUCH AS A MAGNET AND MANUAL EXAMINATION, THE DOCTOR COULD NOT FIND OR FEEL THE SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22485162 ↗
• InjuryJul 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE CUSTOMER WENT TO EMERGENCY ROOM BECAUSE OF BLEEDING AND PAIN AT THE INSERTION SITE AFTER SENSOR REMOVAL WAS PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 22408144 ↗
• MalfunctionJun 19, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON 20 MAY 2025,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 22294071 ↗
• InjuryApr 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED OF BEING HOSPITALIZED FROM (B)(6) 2025 TO (B)(6) 2025 DUE A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THIS ADVERSE EVENT WAS NOT RELATED TO THE USE OF EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM.

  Patient problems: Myocardial Infarction

  MAUDE report 21905929 ↗
• InjuryApr 21, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED THAT THE PHYSICIAN WAS UNABLE TO REMOVE THE SESNOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872831 ↗
• InjuryJan 29, 2025Adverse 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 INCIDENT WHERE USER REPORTED INFECTION AT INSERTION SITE AND SENSOR WAS REMOVED AFTER SEVERAL COURSES OF ANTIBIOTICS WERE ADMINISTERED.DESPITE MULTIPLE FOLLOW UP ATTEMPTS WITH THE USER TO GATHER MORE DETAILS ABOUT THE INFECTION THE USER WAS NOT RESPONSIVE.

  Patient problems: Skin Infection

  MAUDE report 21270131 ↗
• InjuryNov 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 31 OCTOBER 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED INFECTION AT INSERTION SITE WITH SYMPTOMS OF REDNESS, PAIN AND OOZING. THE PATIENT FIRST NOTICED THE SYMPTOMS ON (B)(6) 2024, FEW DAYS AFTER THE INSERTION. USER HAS BEEN APPLYING PEROXIDE AND ANTIBIOTIC OINTMENT AND INSERTION SITE HAD GOTTEN BETTER AND CONTINUES TO HEAL.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20814286 ↗
• InjuryNov 16, 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 INCIDENT WHERE USER REPORTED BLEEDING AT INSERTION SITE WEEK AFTER SENSOR INSERTION AND IT CONTINUED TO BLEED UNTIL THE SENSOR CAME OUT OF THE ARM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 20701817 ↗
• InjuryOct 29, 2024Difficult to Remove; Difficult to Remove

  ON 30 SEPTEMBER 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE ON (B)(6) 2024.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564029 ↗
• InjuryOct 29, 2024Difficult to Remove; Difficult to Remove

  ON 30 SEPTEMBER 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR SN (B)(6) ON THE FIRST ATTEMPT MADE ON 26 SEPTEMBER 2024

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20563263 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUGUST 7, 2024, SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER EXPERIENCED SEVERE WEAKNESS AND WAS NOT ABLE TO LIFT HER HEAD ON (B)(6) 2024. THE USER WENT TO THE HOSPITAL ON (B)(6) 2024, AND WAS ADMITTED AND DIAGNOSED WITH MYASTHENIA GRAVIS. THE USER HAD AN ADDITIONAL LAB TEST AND AN MRI OF HER HEAD AND NECK, AS WELL AS PHYSICAL THERAPY WHILE IN THE HOSPITAL AND AT OTHER LOCATIONS IN THE FOLLOWING MONTH.

  Patient problems: Autoimmune Disorder; Muscle Weakness/Atrophy

  MAUDE report 20164416 ↗
• MalfunctionSep 6, 2024Failure to Sense; Failure to Sense

  ON AUGUST 7, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED SENSOR INACCURACY WHICH LED TO EARLY SENSOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20163409 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JULY 24, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED AN INFECTION AT THE INSERTION SITE ASSOCIATED WITH PAIN AND PUS COMING FROM THE SITE.

  Patient problems: Abscess; Pain

  MAUDE report 20044459 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JULY 24, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER REPORTED THAT THE HCP PERFORMED THE REMOVAL PROCEDURE OF THE SENSOR (B)(6) AND USED THE SAME INCISION TO INSERT THE NEW SENSOR (B)(6) CAUSING IT NOT TO HEAL PROPERLY.

  Patient problems: Impaired Healing

  MAUDE report 20041151 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 26, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER HAD AN INFECTION AT THE INSERTION SITE. THE USER SQUEEZED ON THE INSERTION SITE TO GET THE BLOOD AND PUS OUT AND DURING THE PROCESS THE SENSOR POPPED OUT OF THE INSERTION SITE.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 19823280 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUNE 22, 2024, SENSEONICS WAS MADE AWARE OF AN EVENT WHERE THE USER'S RIGHT ARM WAS BLEEDING. THE USER WENT TO THE EMERGENCY ROOM WHERE THE HCP BANDAGED THE AREA TO STOP THE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19801634 ↗
• InjuryJul 10, 2024Material Separation; Material Separation

  ON JUNE 11, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE DISTAL TIP OF THE SENSOR BROKE DURING THE REMOVAL PROCEDURE. ALL FRAGMENTS OF THE BROKEN SENSOR WERE SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716137 ↗
• InjuryJul 10, 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 USER WAS UNABLE TO LINK THE NEWLY INSERTED SENSOR WITH THE TRANSMITTER. THE ISSUE PERSISTED AFTER A TRANSMITTER REPLACEMENT. THE USER WAS REFERRED TO THEIR HCP TO DISCUSS NEXT STEPS, SUCH AS ASSISTANCE WITH LOCATING THE SENSOR OR POSSIBLE SENSOR REPLACEMENT. NO FURTHER FOLLOW UP WITH THE USER WAS POSSIBLE DUE TO NON RESPONSE DESPITE OF MULTIPLE COMMUNICATION ATTEMPTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19715847 ↗
• MalfunctionJun 25, 2024Failure to Sense; Failure to Sense

  ON MAY 31, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609937 ↗
• MalfunctionJun 25, 2024Failure to Sense; Failure to Sense

  ON MAY 29, 2024, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609933 ↗
• MalfunctionJun 15, 2024Failure to Sense; Failure to Sense

  ON 17 MAY 2024,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 19544445 ↗
• InjuryJun 13, 2024Positioning Problem; Positioning Problem

  ON MAY 15TH 2024,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER HAS DIFFICULTY PLACING THE TRANSMITTER OVER THE SENSOR DUE TO BILATERAL TORN BICEPS AND PLACEMENT OF THE SENSOR FOR WHICH USER HAS TO GO BACK TO THE HCP FOR AN ADDITIONAL PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 19533124 ↗

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 · Terminated
  Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor