Eversense® Adhesive Patches, 3 30-pack White and 1 10-pack Clear FG-6403-01-300Recalls & reported problems
Senseonics, Incorporated · Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. · Class 3 · Implant
All models of Eversense CGM (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817491021311), received between Nov 1, 2019 and Nov 1, 2019 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fungal Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON AUGUST 19TH, 2019, SENSEONICS WAS MADE AWARE OF AN INCIDENT WHERE THE USER DEVELOPED AN INFECTION AT THE INSERTION SITE.
Patient problems: Fungal Infection
MAUDE report 9268259 ↗
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® Sensor Kit - Retail FG-4201-00-301Senseonics, Incorporated · Continuous Glucose Monitor, Implanted, Adjunctive Use3 reports
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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