Eversense E3 Sensor Kit - DME FG-7200-00-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 334 adverse event reports that list this exact device (DI 00817491022950), received between Sep 22, 2022 and May 7, 2026 — classified as 167 injuries, 167 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (114 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 334 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Difficult to Remove

  ON APRIL 8, 2026, SENSEONICS WAS INFORMED OF AN INCIDENT IN WHICH THE USER REPORTED AN UNSUCCESSFUL SENSOR REMOVAL ATTEMPT THAT OCCURRED IN 2018. THE SENSOR REMAINED IN PLACE UNTIL IT WAS SUCCESSFULLY REMOVED ON (B)(6) 2026. THE USER REPORTED DOING WELL FOLLOWING REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119713 ↗
• InjuryDec 25, 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 GOING TO THE ER DUE TO PAIN AND BLEEDING AT THE SENSOR SITE, WHICH OCCURRED ON (B)(6) 2025; ACCORDING TO THE USER, THE INCISION HAD REOPENED WITH BLOOD DISCHARGE, AND THEY FELT AS THOUGH THE SENSOR WAS COMING OUT OF THEIR ARM ON ITS OWN, PROMPTING THE ER VISIT, ALTHOUGH AT THE TIME OF THE CALL THE USER WAS FEELING OKAY. THE EVENT WAS NOT RELATED TO SENSOR INSERTION OR REMOVAL BUT WAS RELATED TO THE EVERSENSE SYSTEM. THE USER DID NOT RECEIVE TREATMENT AT THE HOSPITAL AND WAS NOT PRESCRIBED ANY MEDICATION. THE USER'S HCP WAS AWARE OF THE EVENT, AND THE USER WAS ADVISED TO CONTINUE FOLLOWING UP WITH THE HCP FOR FURTHER MEDICAL GUIDANCE. PER DMS, THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2024 AT 8:53 AM DUE TO THE SENSOR REACHING END OF LIFE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 23892611 ↗
• InjuryDec 18, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF A INICENT WHERE TERRITORY MANAGER REPORTED AN UNSUCCESSFUL REMOVAL ATTEMPT OF SENSOR ON 18-NOV-2025. THE SENSOR WAS LOCATED IN THE LEFT ARM, AND AN INCISION WAS MADE IN AN ATTEMPT TO REMOVE THE SENSOR. AT THE TIME OF THE CALL, THE USER REPORTED DOING WELL.PRIOR TO THE INCISION, THE SENSOR WAS PALPABLE. THE TRANSMITTER AND MAGNET WERE USED TO LOCALIZE THE SENSOR; ULTRASOUND WAS NOT USED DURING THE REMOVAL ATTEMPT.PER REVIEW OF THE DATA MANAGEMENT SYSTEM (DMS), THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2025 AT 11:35 AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23844724 ↗
• InjuryDec 11, 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 AN UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR SN (B)(6) ON 11-NOV-2025. THE SENSOR'S SITE IS THE UPPER LEFT ARM. IT WAS CONFIRMED THAT AN INCISION WAS MADE TO ATTEMPT TO REMOVE THE SENSOR. SENSOR WAS PALPABLE BEFORE THE INCISION. TRANSMITTER AND MAGNET WAS USED TO LOCALIZE THE SENSOR.

  Patient problems: Pain

  MAUDE report 23785270 ↗
• MalfunctionNov 22, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE PHYSICIAN WAS UNABLE TO REMOVE THE SENSOR ON THE TWO ATTEMPTS MADE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23626924 ↗
• MalfunctionNov 10, 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 SKIN INFECTION AT INSERTION SITE. THE SYMPTOMS WERE MANAGED UNDER THE DIRECTION OF THE USER'S HEALTHCARE PROVIDER, WHO INITIATED CONCOMITANT THERAPY FOR TREATMENT.

  Patient problems: Skin Infection

  MAUDE report 23513096 ↗
• MalfunctionNov 9, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  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 23507468 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 14 JULY 2025, SENSONICS WAS MADE AWARE OF A SERIOUS ADVERSE EVENT WHERE PATIENT REPORTED HYPOTENSION RESULTING IN HOSPITALIZATION.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 22800957 ↗
• MalfunctionAug 9, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON 10 JULY 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 22766689 ↗
• InjuryAug 6, 2025Difficult to Remove; Difficult to Remove

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22734788 ↗
• InjuryAug 3, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR ON (B)(6) 2024. THE SENSOR'S SITE IS THE UPPER LEFT ARM. IT WAS CONFIRMED THAT AN INCISION WAS MADE TO ATTEMPT TO REMOVE THE SENSOR.AT THE TIME OF THE CALL, THE USER WAS HAVING PAIN AND ITCHINESS ON THE INSERTION SITE. SENSOR WAS PALPABLE BEFORE THE INCISION, WITH THE HELP OF THE MAGNET.TRANSMITTER AND ULTRASOUND WASN'T USED TO LOCALIZE THE SENSOR.UPON REVIEW OF DMS, THE USER HAS NOT BEEN USING THE SYSTEM SINCE (B)(6) 2025.

  Patient problems: Pain

  MAUDE report 22696268 ↗
• InjuryJul 31, 2025Imprecision; Imprecision

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPERGLYCEMIC EPISODE.USER EXPERIENCED NAUSEA AND FATIGUE.

  Patient problems: Fatigue; Hyperglycemia; Nausea

  MAUDE report 22683778 ↗
• InjuryJul 31, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR ON (B)(6) 2025. THE SENSOR'S SITE WAS IN THE RIGHT ARM. IT WAS CONFIRMED THAT AN INCISION WAS MADE TO ATTEMPT TO REMOVE THE SENSOR. THE SENSOR WAS PALPABLE BEFORE THE INCISION. TRANSMITTER AND ULTRASOUND WASN'T USED TO LOCALIZE THE SENSOR. PER DMS, USER IS NOT USING THE SYSTEM AS NO NEW SENSOR WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683624 ↗
• InjuryJul 10, 2025Difficult to Remove; Difficult to Remove

  ON 10 JUNE 2025,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR ON THE FIRST ATTEMPT MADE BY HCP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476406 ↗
• MalfunctionJul 2, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON 02 JUNE 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 22391571 ↗
• MalfunctionJun 30, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON (B)(6) 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 22353204 ↗
• InjuryMay 30, 2025Difficult to Remove; Difficult to Remove

  ON 30 APRIL 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A FAILED SENSOR REMOVAL ATTEMPT. PATIENT HAD E3 SENSORS IN BOTH ARMS, INCLUDING THE ONE WITH A PREVIOUSLY UNSUCCESSFUL ATTEMPT IN THE LEFT ARM. MAGNET AND ULTRASOUND WAS USED TO SUCCESSFULLY TO VERIFY LOCATION. BOTH SENSORS WERE REMOVED SUCCESSFULLY BY HCP WITH NO ISSUES REPORTED. THE USER WAS INSERTED WITH A NEW 365 SENSOR IN THE RIGHT ARM IN A NEW LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119864 ↗
• InjuryMay 21, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED AN UNSUCCESSFUL REMOVAL ATTEMPT OF THE SENSOR ON (B)(6)2025. THE SENSOR'S SITE IS THE LEFT ARM. IT WAS CONFIRMED THAT AN INCISION WAS MADE TO ATTEMPT TO REMOVE THE SENSOR. AT THE TIME OF THE CALL, THE USER WAS DOING FINE, BUT TIRED.SENSOR WAS PALPABLE BEFORE THE INCISION. TRANSMITTER AND ULTRASOUND WEREN'T USED TO LOCALIZE THE SENSOR AND ONLY MAGNET WAS USED TO LOCALIZE THE SENSOR.HOWEVER, THE SENSOR WAS SUCCESSFULLY REMOVED DURING SECOND REMOVAL ATTEMPT.AS PER DMS, USER IS CURRENTLY USING THE SYSTEM WITH THE NEW SENSOR AND RECEIVING UP TO DATE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061638 ↗
• InjuryMay 18, 2025Difficult to Remove; Difficult to Remove

  ON 18 APRIL 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A FAILED SENSOR REMOVAL ATTEMPT MADE BY HCP ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041324 ↗
• MalfunctionMay 12, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON 12 APRIL 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER RECEIVED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.TO FURTHER EVALUATE THE ISSUE AND TO DETERMINE THE ROOT CAUSE, A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO BRING THE SENSOR BACK FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006413 ↗
• InjuryMay 2, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE HCP WAS UNABLE TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE.CUTOMER CARE MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE INCIDENT BUT NO RESPONSE FROM THE USER OR HCP.AS PER DMS, IT SHOWS THE USER IS ACTIVELY USING THE SYSTEM.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 21952564 ↗
• InjuryApr 25, 2025Difficult to Remove; Difficult to Remove

  SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER REPORTED A FAILED ATTEMPT TO REMOVE THE SENSOR ON THE FIRST ATTEMPT MADE BY HCP.THE HCP TRIED TO REMOVE THE SENSOR BUT WAS UNABLE TO LOCATE OR REMOVE IT DESPITE USING AN ULTRASOUND AND A LARGE MAGNET.

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

  MAUDE report 21911194 ↗
• 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 INFECTION AT INSERTION SITE AND WANTED TO GET THE SENSOR REMOVED. USER HAD SOME REDNESS AND DRAINAGE AT THE INSERION SITE. CUSTOMER CARE MADE MULTIPLE ATTEMPTS TO CONTACT THE USER TO GATHER ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED. AS PER DMS, THE USER'S SENSOR REACHED END OF LIFE SINCE ON (B)(6) 2025.

  Patient problems: Insufficient Information; Skin Infection

  MAUDE report 21905904 ↗
• MalfunctionApr 23, 2025Imprecision; Imprecision

  ON (B)(6), 2025, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED SENSOR INACCURACY WHICH LED TO AN EARLY SENSOR REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893873 ↗
• MalfunctionApr 17, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator

  ON 18 MARCH 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 21860318 ↗

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