Dexcom Stelo iOS Mobile App SW14116Recalls & reported problems
Dexcom, Inc. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00386270004635), received between May 13, 2025 and Jun 24, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Foreign Body In Patient2
- Foreign Body Reaction1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT A DETACHED OR MISSING SENSOR WIRE OCCURRED. THE BIOSENSOR WAS INSERTED ON (B)(6) 2026. NO DATA WAS PROVIDED FOR EVALUATION. THE ALLEGATION AND THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO SERIOUS OR PROLONGED PATIENT HARM OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Foreign Body In Patient; Foreign Body Reaction; Unspecified Infection
MAUDE report 25610686 ↗MalfunctionJun 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE COMPLAINT STATES THAT "CGM ACCURACY" WAS REPORTED. NO PRODUCT OR DATA WAS PROVIDED FOR INVESTIGATION. PROBLEM COULD NOT BE CONFIRMED AND PROBABLE CAUSE CANNOT BE DETERMINED. IT HAS BEEN REPORTED THAT THERE WAS A DIFFERENCE IN READINGS OF 20 POINTS OFF. THERE WERE NO REPORTED GLUCOSE VALUES AVAILABLE TO SEARCH WITHIN THE PARKES ERROR GRID CALCULATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22167916 ↗MalfunctionMay 13, 2025Break; Break
IT WAS REPORTED THAT A BROKEN 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: Foreign Body In Patient
MAUDE report 22013167 ↗
Other Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter devices
- Stelo Glucose Biosensor (2pk) STP-XN-002Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter612 reports
- Stelo Glucose Biosensor (1pk) STP-XN-001Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter551 reports
- Stelo Biosensor 9500-174Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter290 reports
- Lingo 77263Abbott Diabetes Care Inc · Integrated continuous glucose monitor for non-intensive glucose monitoring, Over-The-Counter33 reports
- Stelo Glucose Biosensor (2pk) STP-XN-003Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter4 reports
- Stelo Glucose Biosensor (2pk) UPC STP-XN-002Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.