Dexcom G7 GSS 9500-151Recalls & reported problems

Summary

The FDA's MAUDE database contains 12,714 adverse event reports that list this exact device (DI 00386270002808), received between Apr 19, 2023 and Sep 16, 2025 — classified as 198 injuries, 12,516 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (9,724 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 12,714 reports, in the reporter's own words as published by the FDA.

• 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 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 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, 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 ↗
• 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 ↗
• MalfunctionAug 26, 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. 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 22896618 ↗
• MalfunctionAug 26, 2025Low Readings; Low 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 ABDOMEN, WHICH IS OFF-LABEL USAGE OF THE DEVICE 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 AND D ZONES OF THE PARKES ERROR GRID. THE DATA INVESTIGATION FOUND A DIFFERENCE IN VALUES THAT FALLS WITHIN THE D ZONE OF THE PARKES ERROR GRID. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hyperglycemia

  MAUDE report 22894045 ↗
• MalfunctionAug 25, 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. THE PRODUCT WAS EVALUATED. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND PASSED. NORDIC BLUETOOTH PAIRING TEST WAS PERFORMED AND FAILED. PERFORMANCE DATA WAS NOT PROVIDED FOR EVALUATION. THE ALLEGATION COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED AS THE ALLEGATION WAS NOT FOUND. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883340 ↗
• MalfunctionAug 19, 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 22846446 ↗
• MalfunctionAug 16, 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 22822648 ↗
• MalfunctionAug 15, 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 22819379 ↗
• MalfunctionAug 12, 2025Wireless Communication Problem; Wireless Communication Problem

  SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786307 ↗
• MalfunctionAug 11, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A SENSOR ISSUE OCCURRED. 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 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 22777052 ↗
• MalfunctionAug 6, 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 22724156 ↗
• MalfunctionAug 5, 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 22717238 ↗
• MalfunctionAug 5, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT A SIGNAL LOSS OCCURRED. IT WAS INDICATED THE PATIENT STARTED THEIR TRANSMITTER PAST THE 'USE BY' DATE, 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 22715998 ↗
• MalfunctionAug 1, 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 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 22688743 ↗
• MalfunctionJul 31, 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 RESTORE THE CONNECTION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679928 ↗
• MalfunctionJul 29, 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 22646354 ↗
• MalfunctionJul 25, 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 22614434 ↗
• MalfunctionJul 24, 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 22594339 ↗
• MalfunctionJul 21, 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 22559510 ↗

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-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-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-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-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