Dexcom G7 GSS (160) STP-AT-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00386270003591), received between Aug 23, 2024 and May 20, 2025 — classified as 51 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (46 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• 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. 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: Hyperglycemia

  MAUDE report 22057866 ↗
• MalfunctionMay 16, 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 THIGH WHICH IS OFF-LABEL USAGE OF THE DEVICE 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: Hypoglycemia

  MAUDE report 22039565 ↗
• MalfunctionMay 14, 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 ESTABLISH A CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22021870 ↗
• MalfunctionMay 14, 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. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND A 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015886 ↗
• MalfunctionMay 13, 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 CONFIRMED. 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 FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 22015749 ↗
• MalfunctionMay 13, 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 CONFIRMED. THE PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. THE REPORTED GLUCOSE VALUES FALL WITHIN THE C ZONE OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALL WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 22011919 ↗
• MalfunctionJan 23, 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 21225688 ↗
• MalfunctionJan 23, 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 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 21225673 ↗
• MalfunctionJan 21, 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 21203359 ↗
• MalfunctionJan 17, 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 21182367 ↗
• MalfunctionJan 15, 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 21160592 ↗
• MalfunctionJan 10, 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. 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 21126276 ↗
• MalfunctionJan 8, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT 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 ONE HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108058 ↗
• MalfunctionJan 8, 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 21106279 ↗
• MalfunctionDec 27, 2024Wireless 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 WAS THE TRANSMITTER AND APP WERE UNABLE TO RESTORE THE CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027969 ↗
• MalfunctionDec 13, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT 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 ONE HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20931732 ↗
• MalfunctionDec 13, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT 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 ONE HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922243 ↗
• MalfunctionDec 11, 2024Wireless 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 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 20909412 ↗
• MalfunctionDec 5, 2024Wireless 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 20858798 ↗
• MalfunctionDec 5, 2024Wireless 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 20858469 ↗
• MalfunctionDec 5, 2024Wireless 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 20858070 ↗
• MalfunctionDec 5, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT 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 ONE HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20856163 ↗
• MalfunctionDec 4, 2024Wireless 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 WAS THE TRANSMITTER AND APP WERE UNABLE TO RESTORE THE CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846728 ↗
• MalfunctionDec 2, 2024Wireless 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 20828131 ↗
• MalfunctionNov 27, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT 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 ONE HOUR WAS FOUND IN CONNECTION TO THE REPORTED ALLEGATION. THE PROBABLE CAUSE OF THE SIGNAL LOSS COULD NOT BE DETERMINED. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800997 ↗

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-2446-2025 · Jul 24, 2025 · Open, Classified
  Brand 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-2447-2025 · Jul 24, 2025 · Open, Classified
  Brand 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, Classified
  Brand 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-1944-2025 · May 12, 2025 · Open, Classified
  Dexcom 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