Eversense® Sensor Kit FG-4200-00-301 (UDI 00817491021410)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 implantable glucose sensor is placed under the skin to track blood sugar. The 82 reports mostly describe the sensor giving inaccurate or unstable readings, sometimes leading to early removal, and some describe it being hard to remove. The reports include 28 injuries 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
- 82
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 00817491021410), received between Oct 30, 2018 and Aug 21, 2020 — classified as 28 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Failure to Sense” (45 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
Device problems
- Failure to Sense45
- Difficult to Remove17
- Adverse Event Without Identified Device or Use Problem10
- Imprecision6
- Communication or Transmission Problem2
- Material Separation2
Patient problems
- No Known Impact Or Consequence To Patient53
- Discomfort11
- Post Operative Wound Infection7
- No Code Available6
- No Consequences Or Impact To Patient2
- Blood Loss1
- Missing Value Reason1
- Pain1
Recent adverse event reports
The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2020Difficult to Remove; Difficult to Remove
ON JULY 23RD 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 10440436 ↗MalfunctionApr 19, 2020Imprecision; Imprecision
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INSTANCE WHERE THE PATIENT EXPERIENCED INACCURACIES IN SENSOR READINGS LEADING TO SENSOR REMOVAL AND REPLACEMENT.
Patient problems: No Code Available
MAUDE report 9975911 ↗MalfunctionApr 19, 2020Imprecision; Imprecision
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INSTANCE WHERE THE PATIENT EXPERIENCED INACCURACIES IN SENSOR READINGS LEADING TO SENSOR REMOVAL AND REPLACEMENT.
Patient problems: No Code Available
MAUDE report 9975909 ↗MalfunctionApr 19, 2020Imprecision; Imprecision
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INSTANCE WHERE THE PATIENT EXPERIENCED INACCURACIES IN SENSOR READINGS LEADING TO SENSOR REMOVAL AND REPLACEMENT.
Patient problems: No Code Available
MAUDE report 9975854 ↗MalfunctionApr 19, 2020Imprecision; Imprecision
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE PATIENT EXPERIENCED UNSTABLE SENSOR READINGS AND THE SENSOR GLUCOSE READINGS HAVING LOT OF VARIABILITY.
Patient problems: No Code Available
MAUDE report 9975852 ↗MalfunctionApr 19, 2020Imprecision; Imprecision
ON (B)(6) 2019,SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER COMPLAINTS OF INACCURACIES IN SENSOR READINGS RESULTING IN SENSOR REMOVAL.
Patient problems: No Code Available
MAUDE report 9975850 ↗InjuryApr 9, 2020Imprecision; Imprecision
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF A SITUATION WHERE A DEVICE IS TO BE REMOVED EARLY DUE TO SENSOR INACCURACY.
Patient problems: No Code Available
MAUDE report 9944386 ↗InjuryApr 9, 2020Communication or Transmission Problem; Communication or Transmission Problem
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF A SITUATION WHERE USER EXPERIENCED CONSTANT DISCONNECTIONS BETWEEN TRANSMITTER AND SENSOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9944355 ↗InjuryApr 9, 2020Communication or Transmission Problem; Communication or Transmission Problem
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF A SITUATION WHERE USER EXPERIENCED CONSTANT DISCONNECTIONS BETWEEN TRANSMITTER AND SENSOR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9944235 ↗MalfunctionMar 15, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9833275 ↗MalfunctionMar 15, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9833271 ↗MalfunctionMar 15, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9833267 ↗MalfunctionMar 15, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9833260 ↗MalfunctionMar 15, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9833253 ↗MalfunctionMar 15, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9833252 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832561 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832430 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832316 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832274 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832208 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832134 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832113 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832088 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832073 ↗MalfunctionMar 13, 2020Failure to Sense; Failure to Sense
ON (B)(6) 2018, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED AN EARLY SENSOR REPLACEMENT ALERT RESULTING IN AN EARLY SENSOR REMOVAL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9832026 ↗
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 - 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.
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