Stelo Glucose Biosensor (1pk) STP-XN-001Recalls & reported problems
Dexcom, Inc. · Stelo Glucose Biosensor US (1pk) · Class 2
Quick summary
This Stelo glucose biosensor from Dexcom is an over-the-counter continuous glucose sensor worn on the back of the upper arm. The FDA database holds 540 reports for it, many describing sensor parts detaching or breaking, and some mentioning pieces left in the body. There were 38 injuries and no deaths. No recalls name this device. Reports rose from 96 in the previous 12 months to 444 in the last 12 months.
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
- 551
- Deaths reported
- 0
- Injuries reported
- 39
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 551 adverse event reports that list this exact device (DI 00386270004345), received between May 1, 2025 and Sep 30, 2026 — classified as 39 injuries, 512 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (295 reports).
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
- Detachment of Device or Device Component295
- Appropriate Device Problem Term/Code Not Available125
- Break93
- Adverse Event Without Identified Device or Use Problem24
- Wireless Communication Problem12
- Unintended Electrical Shock4
- Incorrect, Inadequate or Imprecise Result or Readings3
- Application Program Freezes or Fails to Launch1
Patient problems
- No Clinical Signs, Symptoms or Conditions390
- Foreign Body In Patient103
- Pain38
- Erythema37
- Bacterial Infection18
- Skin Inflammation/ Irritation16
- Hemorrhage/Blood Loss/Bleeding15
- Insufficient Information10
Recent adverse event reports
The 25 most recent of 551 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Appropriate Device Problem Term/Code Not Available
It was reported that a wearable failure occurred. The biosensor was inserted into the back of upper arm on (b)(6) 2026. On (b)(6) 2026 the wearable failed. The customer replied ¿yes¿ to the medical intervention question, and indicated they had unspecified hypoglycemia symptoms. The consumer described the medical intervention as ¿hospital.¿ At the time of the report on (b)(6) 2026 they were recovering. Although requested, no other details were provided, and they did not respond to additional requests for information. Data has been requested but is pending evaluation. A follow up report will be submitted upon completion. No additional event or patient information is available.
Patient problems: Hypoglycemia; Insufficient Information
MAUDE report 50947727 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. 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 50947348 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939726 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted on (b)(6)2026. Data was received but not investigated as data will not confirm the issue. 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 50936222 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923347 ↗MalfunctionSep 28, 2026Wireless Communication Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923094 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. Data was received but not investigated as data will not confirm the issue. 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 50916822 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. Data was received but not investigated as data will not confirm the issue. 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 50916812 ↗MalfunctionSep 28, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into the back of the upper arm on (b)(6)-2026. Data was received but not investigated as data will not confirm the issue. 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 50915800 ↗MalfunctionSep 11, 2026Wireless Communication Problem
It was reported that "Signal Loss" occurred. No product or data was provided for investigation. The allegation and the probable cause cannot be determined. No injury or medical intervention was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735344 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted on (b)(6)2026. Data was received but not investigated as data will not confirm the issue. 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 50554613 ↗MalfunctionSep 1, 2026Appropriate Device Problem Term/Code Not Available
It was reported that a broken or detached wire occurred. The sensor was inserted on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. 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 50554436 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50552529 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549337 ↗MalfunctionSep 1, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into the back of the upper arm on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. The allegation and a probable cause could not be determined. No injury or medical intervention was reported.
Patient problems: Erythema
MAUDE report 50548662 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
It was reported that a detached or missing sensor wire occurred. The sensor was inserted into the back of the upper arm on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. 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 50524561 ↗MalfunctionAug 31, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523756 ↗MalfunctionAug 29, 2026Unintended Electrical Shock
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509984 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506637 ↗MalfunctionAug 28, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50503518 ↗MalfunctionAug 27, 2026Appropriate Device Problem Term/Code Not Available
It was reported that a broken or detached wire occurred. The sensor was inserted on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. 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 50487971 ↗MalfunctionAug 27, 2026Appropriate Device Problem Term/Code Not Available
It was reported that a broken or detached wire occurred. The sensor was inserted on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. 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 50487344 ↗MalfunctionAug 27, 2026Break
It was reported that a broken sensor wire occurred. The sensor was inserted into the back of the upper arm on (b)(6) 2026. Data was received but not investigated as data will not confirm the issue. 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 50483051 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50465122 ↗MalfunctionAug 26, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463592 ↗
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 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
- Dexcom Stelo iOS Mobile App SW14116Dexcom, Inc. · Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter3 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.