Dexcom G7 GSSRecalls & reported problems across all models
Dexcom, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19,910
- Deaths reported
- 0
- Injuries reported
- 243
- Recalls
- 0
We found 4 models of Dexcom G7 GSS by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 19,910 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2023 and Jan 3, 2026 — classified as 243 injuries, 19,667 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (15,045 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Dexcom G7 GSS problems
Device problems
- Wireless Communication Problem15,045
- Incorrect, Inadequate or Imprecise Result or Readings1,985
- Detachment of Device or Device Component985
- Premature End-of-Life Indicator769
- Appropriate Device Problem Term/Code Not Available609
- Break216
- Connection Problem163
- Adverse Event Without Identified Device or Use Problem38
Patient problems
- No Clinical Signs, Symptoms or Conditions18,053
- Hyperglycemia1,416
- Hypoglycemia286
- Foreign Body In Patient74
- Loss of consciousness61
- Dizziness56
- Diaphoresis40
- Shaking/Tremors39
Dexcom G7 GSS models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dexcom G7 GSS 9500-151Integrated Continuous Glucose Monitoring System, Factory Calibrated12,714 reports
- Dexcom G7 GSS 9500-155Integrated Continuous Glucose Monitoring System, Factory Calibrated7,118 reports
- Dexcom G7 GSS STP-AT-011Integrated Continuous Glucose Monitoring System, Factory Calibrated65 reports
- Dexcom G7 GSS STP-AT-012Integrated Continuous Glucose Monitoring System, Factory Calibrated13 reports
Recent Dexcom G7 GSS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2026Protective Measures Problem
DEXCOM BECAME AWARE THAT THE USER EXPERIENCED A FAILURE BUT DID NOT RECEIVE THE EXPECTED SENSOR FAILURE ALERT ON THEIR G7 CGM APPLICATION. DATA WAS PROVIDED AND AN INVESTIGATION WAS PERFORMED. THE ROOT CAUSE WAS DETERMINED TO BE A CODING ISSUE. THE G7 CGM APPLICATION ONLY DETECTS THAT THE SESSION HAS ENDED, THUS, IT DOES NOT ALERT THE USER THAT THE SENSOR HAS FAILED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952876 ↗MalfunctionSep 16, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. DATA WAS RECEIVED BUT DOES NOT REFLECT FULL INVESTIGATION WINDOW. 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 23067558 ↗MalfunctionSep 11, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. 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 23030877 ↗MalfunctionSep 10, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT A NO READINGS/SENSOR ERROR/BRIEF SENSOR ISSUE OCCURRED. PERFORMANCE DATA WAS REVIEWED. NO READINGS/SENSOR ERROR/BRIEF SENSOR ISSUE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, SIGNAL LOSS OVER AN HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS WAS DETERMINED TO BE THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23023013 ↗MalfunctionSep 9, 2025Wireless Communication Problem; Wireless 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 23012325 ↗MalfunctionSep 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22979641 ↗MalfunctionSep 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22979478 ↗MalfunctionSep 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22978752 ↗MalfunctionSep 5, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22978618 ↗MalfunctionSep 5, 2025Wireless Communication Problem; Wireless 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 22978198 ↗MalfunctionSep 4, 2025Premature End-of-Life Indicator; Premature End-of-Life Indicator
IT WAS REPORTED THAT EARLY SENSOR EXPIRATION OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM. 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 22974192 ↗MalfunctionSep 3, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. IT WAS INDICATED THE PATIENT STARTED THEIR TRANSMITTER PAST THE 'USE BY' DATE, WHICH IS MISUSE OF THE DEVICE. PERFORMANCE DATA WAS REVIEWED. THE ALLEGATION WAS CONFIRMED DUE TO THE FINDING OF SIGNAL LOSS OVER AN HOUR WITHIN THE INVESTIGATION WINDOW. THE PROBABLE CAUSE WAS THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22953415 ↗MalfunctionAug 29, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT A PAIRING ISSUE OCCURRED. PERFORMANCE DATA WAS REVIEWED. A PAIRING ISSUE WAS NOT FOUND WITHIN THE INVESTIGATION WINDOW. THE ALLEGATION WAS NOT CONFIRMED. HOWEVER, SIGNAL LOSS OVER AN HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS WAS DETERMINED TO BE THE TRANSMITTER AND APP WERE UNABLE TO ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928435 ↗MalfunctionAug 29, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SENSOR NOT WORKING OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. DATA WAS EVALUATED AND THE ALLEGATION WAS CONFIRMED AS SIGNAL LOSS GREATER THAN AN HOUR WAS CONFIRMED. THE PROBABLE CAUSE WAS DETERMINED TO BE SIGNAL LOSS DUE TO THE TRANSMITTER AND APP WERE NOT BEING ABLE TO ESTABLISH A CONNECTION. THE REPORTED EVENT OF A SENSOR NOT WORKING IS REPORTABLE BASED ON THE FINDING OF SIGNAL LOSS GREATER THAN AN HOUR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22927240 ↗InjuryAug 27, 2025Low Readings; Low Readings
IT WAS REPORTED THAT AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER OCCURRED. THE WEARABLE WAS INSERTED INTO THE ARM ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS SHOWING SYMPTOMS OF DIABETIC KETOACIDOSIS (DKA). SHE FELT LIGHTHEADED, "SMELLING OF KETONES", NAUSEA AND VOMITING. THE CGM WAS DISPLAYING 315 MG/DL WHILE THE BG WAS OVER 600 MG/DL. THE PATIENT WAS TAKEN TO THE EMERGENCY DEPARTMENT AND TREATED WITH IV FLUIDS. LABORATORY TESTS WERE ALSO DONE. RESULTS SHOWED THAT THE PATIENT WAS NOT IN DKA. THE PATIENT WAS DISCHARGED THE SAME EVENING WHEN THEY STABILIZED. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE B ZONE OF THE PARKES ERROR GRID. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.
Patient problems: Dizziness; Hyperglycemia; Nausea; Vomiting
MAUDE report 22909680 ↗
Other Dexcom, Inc. products
- Dexcom G613 models · 637,302 reports · 7 recalls
- Dexcom G6 Transmitter2 models · 469,968 reports
- Dexcom G732 models · 325,909 reports · 8 recalls
- Dexcom G521 models · 206,314 reports · 1 recall
- Dexcom G7 GSS (161)4 models · 141,244 reports · 1 recall
- Dexcom G4 Platinum41 models · 119,308 reports · 2 recalls
- Dexcom G7 Receiver4 models · 33,732 reports · 1 recall
- Dexcom G7 GSS (160)4 models · 33,558 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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