Dexcom G7 GSS (155) STP-AT-013Recalls & reported problems
Dexcom, Inc. · G7 US Medicare Sensor/Transmitter 1-pack · Class 2
All models of Dexcom G7 (32) · Dexcom G7 GSS (155) (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dexcom continuous glucose sensor is a sensor and transmitter worn on the arm to track blood sugar. Its 182 reports include no deaths and no injuries. Most describe wireless signal loss between the transmitter and the app, and some note parts detaching. There are no reports in the last 12 months, compared with 123 in the prior 12 months, and 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
- 182
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 00386270003430), received between May 16, 2024 and Oct 22, 2025 — classified as 182 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (159 reports).
4 other recalls cover devices cleared under the same FDA submission (K213919); 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.
Reports received per month
Most reported problems
Device problems
- Wireless Communication Problem159
- Detachment of Device or Device Component12
- Appropriate Device Problem Term/Code Not Available5
- Break2
- Incorrect, Inadequate or Imprecise Result or Readings2
- Overheating of Device2
- Premature End-of-Life Indicator1
Patient problems
- No Clinical Signs, Symptoms or Conditions180
- Hyperglycemia2
Recent adverse event reports
The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. CUSTOMER ADVOCACY. COMPLAINT IS NOT REPORTABLE PER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23361221 ↗MalfunctionMay 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or 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. 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 22056284 ↗MalfunctionMay 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or 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. 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 22054171 ↗MalfunctionMay 15, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 22032035 ↗MalfunctionMay 15, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT SIGNAL LOSS OCCURRED. 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 22032031 ↗MalfunctionMay 15, 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 PASSED. 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 COMPLETE A DATA TRANSFER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22027686 ↗MalfunctionMay 13, 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 ARM ON (B)(6) 2025. PRODUCT HAS BEEN RECIEVED 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 22015344 ↗MalfunctionMay 13, 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 ARM 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 22015103 ↗MalfunctionMay 13, 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 ARM 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 22014257 ↗MalfunctionMay 13, 2025Break; Break
IT WAS REPORTED THAT DAMAGED WIRE 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 22013886 ↗MalfunctionMay 13, 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 ARM 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 22013680 ↗MalfunctionMay 13, 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 ARM ON (B)(6) 2025. PRODUCT WAS PROVIDED FOR INVESTIGATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. AN INTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. THE ALLEGATION WAS UNDETERMINED VIA PRODUCT. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22013665 ↗MalfunctionMay 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A WIRE/NEEDLE/CANNULA DAMAGED OR MISSING OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2025. 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 22013462 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 5/3/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012653 ↗MalfunctionMay 13, 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 22012153 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 5/3/2025. IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010703 ↗MalfunctionMay 13, 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 ARM ON (B)(6)2025. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22010702 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 5/2/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22009666 ↗MalfunctionMay 12, 2025Break; Break
IT WAS REPORTED THAT A BROKEN SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ARM 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 22006870 ↗MalfunctionMay 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT MISSING WIRE 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 22006635 ↗MalfunctionMay 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT A WIRE/NEEDLE/CANNULA DAMAGED OR MISSING 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 22006102 ↗MalfunctionMay 12, 2025Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT WIRE/NEEDLE/CANNULA DAMAGED OR MISSING 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 22006099 ↗MalfunctionMay 12, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 5/04/2025 IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22006095 ↗MalfunctionMay 12, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT 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 22006089 ↗MalfunctionMay 12, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT UNSPECIFIED ISSUE OCCURRED. THE SENSOR WAS INSERTED 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 UNSPECIFIED ISSUE 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 22005950 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213919. One submission often covers many models, so check the product and lot details in each record.
- Z-2447-2025 · Jul 24, 2025 · Open, ClassifiedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: version 2.8.0 and earlier Product Des
- Z-2448-2025 · Jul 24, 2025 · Open, ClassifiedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Produc
- Z-2446-2025 · Jul 24, 2025 · Open, ClassifiedBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product
- Z-1944-2025 · May 12, 2025 · Open, ClassifiedDexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK-AT-013 (MT26403-0), STK-GT-001 (MT26403-1), STK-GT-008 (MT26403-5), STK-GT-013
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.
How reports and recalls are matched · Editorial policy · Report an error on this page