Glucose Monitor Risks, Complications and Recalls
Continuous glucose monitors (CGMs) provide near real‑time blood glucose data for people with diabetes. Studies show they can improve glycemic control and increase the time spent in a normal blood glucose range. But they can also fail or be recalled, creating safety and legal concerns.
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What Are Glucose Monitors?
Diabetes glucose monitors are devices that measure glucose levels in the blood. Monitoring glucose levels can help doctors and patients see how well their treatment plan is working and make better treatment decisions. It can also help patients avoid dangerously high or low blood sugar levels.
Traditional blood glucose monitors use fingersticks with blood samples inserted manually into a meter.
Continuous glucose monitors (CGMs) use sensors implanted under the skin to measure glucose continuously in interstitial fluid (the fluid between cells). A transmitter sends information from the sensor to a smartphone app, a receiver or an insulin pump.
Manufacturers and Brands of Continuous Glucose Monitors for Diabetes
Major manufacturers of CGMs include Dexcom, Abbott and Medtronic. CGMs are growing in popularity because they can provide continuous measurements of blood sugar and alert patients about high or low blood sugar.
They can also help administer insulin when connected to an insulin delivery device.
- Dexcom CGMs:
- Dexcom G6 (will be discontinued in July 2026), Dexcom G6 Pro (will be discontinued in July 2026), Dexcom G7, Dexcom G7 15 Day, Stelo
- Abbott CGMs:
- FreeStyle Libre 2, Libre 2 Plus, Libre 3, Libre 3 Plus, Libre Pro, MiniMed 780G, Lingo
- Medtronic CGMs:
- Guardian 4 Sensor, Simplera Sync
- Other CGMs:
- Eversense 365 (Senseonics)
While all CGMs work similarly — using a sensor, a transmitter and an app or receiver — each of these brands has slightly different features. Make sure you discuss with your medical provider which CGM may be right for you.
Benefits of Continuous Glucose Monitors
Continuous glucose monitors provide several benefits for glucose management, such as avoiding or delaying serious complications of diabetes.
- Ability to share glucose with family and diabetes care team
- Adjust insulin based on glucose trends
- Can customize how pumps deliver insulin and how much is delivered
- Greater peace of mind and reduced stress and anxiety
- May prevent hypoglycemia or hyperglycemia
- Measures glucose levels throughout the day and night
- Provides alerts when glucose is too low or too high
Caregivers and health care providers of the person with diabetes may also benefit from CGMs, because CGM data can be shared with others.
Caregivers can help monitor blood glucose levels, especially in children with diabetes, and avoid hospitalizations. Health care providers have more glucose data to adjust treatments for patients.
CGMs vs. Traditional Blood Glucose Monitors
CGMs and traditional blood glucose monitors or blood glucose meters (BGM) both track glucose levels, but they measure in different ways. While CGMs use interstitial fluid to measure glucose, BGMs use blood to measure glucose.
Readings from BGMs are instant. But because glucose reaches the blood before it reaches interstitial fluid, there can be a delay of about 15 minutes for CGMs to register higher glucose levels after eating. Readings can differ when blood sugar rapidly rises or falls.
Common Glucose Monitor Complications and Device Failures
While there are several potential benefits of CGMs, they also have drawbacks related to the technology that makes them work.
In one study in the Journal of Diabetes Science and Technology, researchers searched the FDA’s MAUDE medical device database for adverse event reports related to CGMs and other diabetes devices.
Between January 2019 and December 2024, they found 1,624,664 adverse event reports for CGMs. The most common issue was a “wireless communication problem” for 536,306 reports.
- Faulty sensors leading to inaccurate readings
- Inaccurate readings leading to potential misinterpretation and incorrect treatments
- Issues with the sensor adhering properly to the skin, especially when doing physical activities
- Smartphone compatibility requirements
- Software glitches and connectivity problems
Patients must also manage sensor insertions, adhesives, alerts, device costs and occasional fingerstick confirmation when data doesn’t match symptoms or the device is improperly calibrated. This might increase stress for some people.
Health Risks From Device Failures
When glucose monitor failures occur, health risks range from mild discomfort to life‑threatening events.
- Diabetic Ketoacidosis (DKA)
- Sustained hyperglycemia can lead to DKA, especially in people with insulin-dependent diabetes. DKA is a potentially fatal medical emergency and may require hospitalization or intensive care.
- Long-Term Health Complications
- Repeated uncontrolled glucose highs and lows raise the risk of long‑term complications such as nerve, kidney and eye damage, along with cardiovascular disease.
- Severe Hypoglycemia
- Complications from dangerously low blood glucose include seizures, loss of consciousness, impaired judgment, difficulty driving and permanent neurological damage.
The severity of the injury depends on how long the problem persists, the patient’s underlying health conditions and whether backup glucose monitoring or clinical care is available.
Warning Signs Your Glucose Monitor May Be Unsafe
Warning signs your glucose monitor may be unsafe include frequent sensor failures, large discrepancies between CGM and meter values, missing alerts, unexplained gaps in data or significant skin reactions at the insertion site.
People who experience severe highs or lows, even if their CGM readings appear normal, or who learn that their device model is subject to a recall, should contact their medical provider right away.
Glucose Monitor Recalls and FDA Safety Warnings
Dexcom and Abbott have both issued high‑profile continuous glucose monitor (CGM) recalls and received FDA‑flagged safety actions in the last few years. These diabetes glucose monitor recalls are mostly tied to missed or incorrect alerts and inaccurate sensor readings, which can potentially lead to dangerous highs or lows.
Most Recent Dexcom CGM Recalls
Dexcom’s recent recalls have largely involved its stand‑alone receivers and smartphone apps.
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June 2025
Dexcom recalled 36,824 G6 receivers and 602,445 G7 receivers worldwide due to defective foam that could cause the speaker to not work properly. This could prevent audible high and low alerts, leading to missed detection of severe hypoglycemia or hyperglycemia. Dexcom ONE and ONE+ receivers are also a part of this recall, but are not sold in the U.S.
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October 2025
Dexcom recalled 333 Dexcom G6 CGMs because of Android mobile app problems. The app could crash unexpectedly, leaving people without glucose data or alarms. These events raised concern about delayed treatment of glucose highs or lows, diabetic ketoacidosis (DKA) and other complications.
Dexcom urged customers to check if their devices are affected by the June 2025 receiver recall and to contact the company for a replacement. For the Android app recall, customers had to upgrade their app to a newer version.
Most Recent Abbott CGM Recalls
In December 2025, Abbott recalled its FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors because they could provide incorrect low glucose readings.
The incorrect low readings could lead to excessive carbohydrate intake, or skipping or delaying insulin. This can lead to potential injury or death.
As of November 2025, there have been 736 serious injuries and seven deaths reportedly associated with the recalled sensors.
How To Check If Your Glucose Monitor Has Been Recalled
You can check if your Dexcom device is recalled by looking for the serial numbers posted on the FDA’s recall alert. Dexcom’s U.S. site also allows you to enter your device’s serial number and check if it’s been recalled.
You can check the FDA’s Abbott recall notification for instructions on how to determine if your FreeStyle Libre sensor is recalled.
What To Do if Your Glucose Monitor Fails
If a glucose monitor fails, patients should prioritize safety by treating suspected highs or lows according to their diabetes plan, confirm their blood glucose measurements with a backup meter if possible and seek medical care for severe symptoms.
Clinicians can help determine whether you should discontinue the device, switch to an alternative and document the event for regulatory and legal purposes.
- Seek urgent or emergency care for severe symptoms such as confusion, chest pain, difficulty breathing, vomiting or signs of DKA. Bring your device information to the visit.
- Treat symptoms of hypoglycemia according to your emergency plan by eating or drinking foods to get your blood sugar up.
- Use a fingerstick meter if your CGM data seems unreliable.
Patients and health professionals can report suspected device‑related problems, injuries or malfunctions to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program online, by mail or by phone. These reports support surveillance, recalls and safety communications for glucose monitors and other medical devices.
Who Is Responsible for Defective Glucose Monitors?
Manufacturers are mainly responsible for warning the public about defective glucose monitors. They must investigate complaints, correct defects and initiate recalls or field corrections when safety issues arise.
When To Consider Talking With a Lawyer About a Glucose Monitor Recall
Patients may consider speaking with a lawyer about a Dexcom glucose monitor lawsuit or other CGM lawsuit if they experienced serious injury, such as severe hypoglycemia, DKA, hospitalization or long‑term harm that they believe is linked to a recalled or defective glucose monitor.
Legal counsel can review device model and lot numbers, recall status, medical records and manufacturer communications to see if you qualify to file a lawsuit.
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