Dexcom G7 GSS STP-AT-012Recalls & reported problems
Dexcom, Inc. · G7 US Retail Sensor/Transmitter 1-pack · Class 2
All models of Dexcom G7 (32) · Dexcom G7 GSS (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00386270002839), received between Mar 17, 2025 and May 13, 2025 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component13
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2025Break; Detachment of Device or Device Component; Break; 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 REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22014540 ↗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 REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22014502 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 5/5/2025 AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22014393 ↗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 22014373 ↗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 22014348 ↗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 22014205 ↗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 22013660 ↗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 22012643 ↗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 22012629 ↗MalfunctionMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER SUBMISSION OF THE INITIAL MDR, PRODUCT WAS RECEIVED ON 8/19/2025, AND IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22012627 ↗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 22012621 ↗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. 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 22012619 ↗MalfunctionMar 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AFTER SUBMISSION OF THE INITIAL MDR PRODUCT WAS RECEIVED ON 3/12/2025 IT WAS DETERMINED THIS COMPLAINT IS NOT REPORTABLE PER CORPFT-140202.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21620238 ↗
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, 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-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-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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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