Dexcom G7 GSS (161) STP-AT-011Recalls & reported problems
Dexcom, Inc. · G7 US DME Sensor/Transmitter 1-pack · Class 2
All models of Dexcom G7 (32) · Dexcom G7 GSS (161) (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dexcom G7 is a wearable glucose monitoring sensor. Of its 6,208 reports, none are deaths and 166 are injuries. Many describe wireless communication problems, sensors detaching, and low or high readings, and some recent reports describe early sensor expiration. Reports rose from 1,649 in the prior year to 4,429 in the latest year. 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
- 6,223
- Deaths reported
- 0
- Injuries reported
- 166
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6,223 adverse event reports that list this exact device (DI 00386270004093), received between May 13, 2024 and Sep 30, 2026 — classified as 166 injuries, 6,056 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (2,188 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Wireless Communication Problem2,188
- Detachment of Device or Device Component1,704
- Low Readings1,357
- High Readings361
- Break291
- Incorrect, Inadequate or Imprecise Result or Readings109
- Premature End-of-Life Indicator99
- Appropriate Device Problem Term/Code Not Available46
Patient problems
- No Clinical Signs, Symptoms or Conditions4,317
- Hyperglycemia1,397
- Hypoglycemia285
- Foreign Body In Patient148
- Nausea41
- Loss of consciousness37
- Vomiting36
- Hypoglycemic Shock29
Recent adverse event reports
The 25 most recent of 6,223 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949897 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939047 ↗MalfunctionSep 29, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938575 ↗OtherSep 25, 2026Defective Alarm
It was reported that an alert/notification settings issue occurred. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No serious or prolonged patient harm or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895750 ↗MalfunctionSep 24, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. It was indicated that a sensor insertion into the abdomen occurred on (b)(6)-2026, which is an off-label misuse of the device. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined, and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50887934 ↗MalfunctionSep 24, 2026Wireless Communication Problem
It was reported that a signal loss occurred. It was indicated that the patient was using an unsupported operating system, which is misuse of the device. No product or data was provided for evaluation. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885439 ↗MalfunctionSep 22, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on (b)(6) 2026. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857373 ↗MalfunctionSep 18, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on (b)(6) 2026. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined, and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820553 ↗MalfunctionSep 16, 2026Wireless Communication Problem
It was reported that signal loss occurred. Product has been received but is pending evaluation. A follow up report will be submitted upon completion. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788258 ↗MalfunctionSep 15, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779809 ↗MalfunctionSep 15, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50779180 ↗MalfunctionSep 10, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50722819 ↗MalfunctionSep 10, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719968 ↗MalfunctionSep 10, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on an unknown date. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719951 ↗MalfunctionSep 10, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on an unknown date. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50719920 ↗MalfunctionSep 8, 2026Inappropriate or Unexpected Reset
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677407 ↗MalfunctionAug 27, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on (b)(6) 2026. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50487862 ↗MalfunctionAug 26, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50464466 ↗MalfunctionAug 25, 2026Wireless Communication Problem
Subsequent to the initial MDR, a correction is required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435579 ↗MalfunctionAug 18, 2026Low Readings
It was reported that an inaccuracy between the Continuous Glucose Monitor (CGM) and the Blood Glucose (BG) meter occurred. The sensor was inserted into the arm on (b)(6) 2026. Data was evaluated and the allegation was undetermined. The probable cause could not be determined via data. The reported glucose values fall within the D zone of the Parkes Error Grid. The data investigation did not find blood glucose calibration values to compare to CGM values during the reported sensor session or the calibrations during the reported sensor session were in accurate range per device specifications. No injury or medical intervention was reported.
Patient problems: Hyperglycemia
MAUDE report 50302585 ↗MalfunctionAug 18, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290639 ↗MalfunctionAug 17, 2026Premature End-of-Life Indicator
It was reported that early sensor expiration occurred. The sensor was inserted into the arm on (b)(6) 2026. No relevant product or data related to the issue was provided for investigation. Confirmation of the complaint is undetermined and probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50290004 ↗MalfunctionAug 17, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289998 ↗MalfunctionAug 17, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50289456 ↗MalfunctionJul 28, 2026Premature End-of-Life Indicator
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50049265 ↗
Other Integrated Continuous Glucose Monitoring System, Factory Calibrated devices
- Dexcom G6 Transmitter 9445-24Dexcom, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated240,475 reports
- 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 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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