Dexcom G7 GSS (160)Recalls & 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
- 33,558
- Deaths reported
- 0
- Injuries reported
- 372
- Recalls
- 0
We found 4 models of Dexcom G7 GSS (160) by Dexcom, Inc. in the FDA's device registry (GUDID). Together they are named in 33,558 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2023 and Sep 15, 2026 — classified as 372 injuries, 33,186 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (17,039 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 (160) problems
Device problems
- Wireless Communication Problem17,039
- Detachment of Device or Device Component7,417
- Incorrect, Inadequate or Imprecise Result or Readings4,418
- Break1,778
- Premature End-of-Life Indicator1,535
- Appropriate Device Problem Term/Code Not Available995
- Display or Visual Feedback Problem149
- Unintended Application Program Shut Down142
Patient problems
- No Clinical Signs, Symptoms or Conditions29,513
- Hyperglycemia3,079
- Hypoglycemia612
- Foreign Body In Patient209
- Loss of consciousness96
- Dizziness90
- Erythema56
- Fatigue55
Dexcom G7 GSS (160) models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Dexcom G7 GSS (160) 9500-160Integrated Continuous Glucose Monitoring System, Factory Calibrated33,025 reports
- Dexcom G7 GSS (160) STP-AT-012Integrated Continuous Glucose Monitoring System, Factory Calibrated317 reports
- Dexcom G7 GSS (160) STP-AT-013Integrated Continuous Glucose Monitoring System, Factory Calibrated165 reports
- Dexcom G7 GSS (160) STP-AT-011Integrated Continuous Glucose Monitoring System, Factory Calibrated51 reports
Recent Dexcom G7 GSS (160) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782193 ↗MalfunctionMar 4, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT AN APPLICATOR DEPLOYMENT OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED DUE TO MISSING NEEDLE. AN APPLICATOR DEPLOYMENT 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 24506301 ↗MalfunctionFeb 18, 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. PRODUCT 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 24380206 ↗MalfunctionJan 12, 2026Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND FAILED. 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 COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24045556 ↗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 23953030 ↗MalfunctionDec 31, 2025Protective Measures Problem; Protective 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 23938780 ↗MalfunctionDec 31, 2025Protective Measures Problem; Protective 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 23938713 ↗MalfunctionDec 4, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND FAILED. 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 COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720093 ↗MalfunctionDec 4, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND FAILED. 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 COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23718012 ↗MalfunctionSep 18, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND FAILED. 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 COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23089054 ↗MalfunctionSep 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2025. 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 23066042 ↗MalfunctionSep 16, 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 23062920 ↗MalfunctionSep 16, 2025High Readings; High 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) 2025. IT WAS INDICATED THAT THE PATIENT USED AN EXPIRED SENSOR, WHICH IS MISUSE OF THE DEVICE. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. THE REPORTED GLUCOSE VALUES FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Hypoglycemia
MAUDE report 23062138 ↗MalfunctionSep 15, 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 23058073 ↗MalfunctionSep 12, 2025Wireless Communication Problem; Wireless Communication Problem
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 9/10/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042407 ↗
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 G5 Mobile Receiver3 models · 26,327 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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