Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System STP-FT-012Recalls & reported problems
Dexcom, Inc. · G7 15 Day US Retail Sensor 1pk · Class 2
Quick summary
This Dexcom G7 15 Day sensor has 4,019 adverse event reports, with 112 injuries, 3,904 malfunctions and no deaths. The reports mostly describe signal loss, low or high readings that did not match fingerstick meters, and sensors detaching or breaking. No recalls name this device. Reports jumped from 1 in the prior 12 months to 4,018 in the latest 12 months.
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
- 5,305
- Deaths reported
- 0
- Injuries reported
- 148
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,305 adverse event reports that list this exact device (DI 00386270004765), received between Sep 4, 2025 and Sep 30, 2026 — classified as 148 injuries, 5,151 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (3,514 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Wireless Communication Problem3,514
- Low Readings944
- Detachment of Device or Device Component392
- High Readings193
- Break83
- Appropriate Device Problem Term/Code Not Available44
- Incorrect, Inadequate or Imprecise Result or Readings41
- Premature End-of-Life Indicator31
Patient problems
- No Clinical Signs, Symptoms or Conditions4,044
- Hyperglycemia933
- Hypoglycemia168
- Foreign Body In Patient107
- Dizziness43
- Vomiting40
- Malaise37
- Nausea37
Recent adverse event reports
The 25 most recent of 5,305 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50955178 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954987 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954982 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954980 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954851 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954752 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954742 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954740 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954613 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954340 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954288 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954279 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953632 ↗MalfunctionSep 30, 2026Low Readings
Patient problems: Hyperglycemia
MAUDE report 50952722 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952694 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952690 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952526 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952472 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952315 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952278 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952032 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952017 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952014 ↗MalfunctionSep 30, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951996 ↗MalfunctionSep 30, 2026Break
It was reported that physical damage occurred. Product was provided for investigation. An external visual inspection was performed and passed. Physical damage was not found within the investigation window. The allegation was not confirmed. However, a broken or detached needle or cannula was found in connection to the reported event. The probable cause of the broken or detached needle or cannula could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951760 ↗
Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices
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- Dexcom G6 Transmitter 9445-02Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 deaths229,493 reports
- Dexcom G6 Sensor Applicator Assembly 9500-45Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall4 deaths114,678 reports
- US G6 Transmitter (Retail, Receiver Optional) STT-OE-002Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated76,977 reports
- Dexcom G7 GSS (161) 9500-161Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated70,146 reports
- Dexcom G7 iOS App SW12300Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated3 recalls1 death55,219 reports
- Dexcom G7 GSS (161) STP-AT-012Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated1 recall5 deaths48,180 reports
- G6 Medicare Transmitter STT-OM-001Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated38,339 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.