Eversense® Sensor Kit - Retail FG-4201-00-301 (UDI 00817491021427)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
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817491021427), received between Jun 20, 2019 and Sep 18, 2019 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (3 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
- Difficult to Remove3
Patient problems
- No Known Impact Or Consequence To Patient2
- Discomfort1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2019Difficult to Remove; Difficult to Remove
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE A PHYSICIAN WAS UNABLE TO EXPLANT THE EVERSENSE SENSOR.
Patient problems: Discomfort
MAUDE report 9084268 ↗MalfunctionJul 17, 2019Difficult to Remove; Difficult to Remove
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INSTANCE WHERE THE PHYSICIAN COULD NOT REMOVE THE EVERSENSE SENSOR ON THE FIRST ATTEMPT. THE PATIENT WAS ASKED TO REVISIT THE HEALTHCARE FACILITY FOR A SECOND REMOVAL ATTEMPT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8799368 ↗InjuryJun 20, 2019Difficult to Remove; Difficult to Remove
ON (B)(4) 2019, SENSEONICS WAS MADE AWARE OF AN INSTANCE WHERE THE PHYSICIAN COULD NOT REMOVE THE EVERSENSE SENSOR ON THE FIRST ATTEMPT. THE PATIENT WAS ASKED TO REVISIT THE HEALTHCARE FACILITY FOR A SECOND REMOVAL ATTEMPT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8718382 ↗
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® 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® 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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