Eversense® Smart Transmsitter Kit - Retail FG-3301-01-001Recalls & reported problems
Senseonics, Incorporated · Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card. · Class 3
All models of Eversense CGM (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00817491021458), received between May 17, 2019 and Dec 19, 2021 — classified as 7 injuries, 1 malfunction.
The most frequently reported specific device problem is “Imprecision” (4 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
- Imprecision4
- Adverse Event Without Identified Device or Use Problem2
- Device Alarm System2
Patient problems
- Hypoglycemia6
- Hyperglycemia2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2021Imprecision; Imprecision
ON 19TH NOVEMBER 2021, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 13040251 ↗MalfunctionNov 25, 2021Imprecision; Imprecision
ON OCTOBER 26TH 2021,SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPOGLYCEMIA DUE TO INACCURACIES IN SENSOR READINGS.
Patient problems: Hypoglycemia
MAUDE report 12876373 ↗InjuryJul 10, 2020Imprecision; Imprecision
ON (B)(6) 2020,SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE USER EXPERIENCED HYPERGLYCEMIA.
Patient problems: Hyperglycemia
MAUDE report 10261354 ↗InjuryJan 16, 2020Imprecision; Imprecision
ON DEC 17TH, 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPOGLYCEMIA EVENT AND THE SYSTEM DID NOT ALERT THE USER.
Patient problems: Hypoglycemia
MAUDE report 9598001 ↗InjuryNov 15, 2019Device Alarm System; Device Alarm System
ON (B)(4) 2019 SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT AND REPORTED THE CONTINUOUS GLUCOSE MONITORING SYSTEM DID NOT ALERT HER. THE USER DID NOT REQUIRE MEDICAL ATTENTION.
Patient problems: Hyperglycemia
MAUDE report 9328150 ↗InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPOGLYCEMIC EVENT AND THE CGM SYSTEM DID NOT ALERT HER.
Patient problems: Hypoglycemia
MAUDE report 9211130 ↗InjuryOct 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER EXPERIENCED A HYPOGLYCEMIA EVENT AND THE SYSTEM DID NOT ALERT.
Patient problems: Hypoglycemia
MAUDE report 9196715 ↗InjuryMay 17, 2019Device Alarm System; Device Alarm System
ON APRIL 25, 2019 SENSEONICS WAS MADE AWARE OF AN ADVERSE EVENT WHERE THE USER EXPERIENCED A HYPERGLYCEMIA EVENT AND REPORTED THE CONTINUOUS GLUCOSE MONITORING SYSTEM DID NOT ALERT HER. THE USER REQUIRED MEDICAL ATTENTION.
Patient problems: Hypoglycemia
MAUDE report 8621541 ↗
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® 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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