Dexcom Lawsuit

If you or someone in your family purchased a Dexcom G6 or G7 monitor or sensor, you may be entitled to compensation.

At Wisner Baum, our attorneys are pursuing a potential case against Dexcom on behalf of individuals who purchased Dexcom G6 and G7 continuous glucose monitors or sensors during the time period January to November 2024, which were marketed as being effective in monitoring consumers’ blood glucose levels and warning consumers if their glucose levels were too low or too high. However, these representations were false, deceptive and inaccurate.

If you or someone in your family purchased one of these devices or sensors between January 2024 and November 2024, please contact our firm to see if you may qualify.

Further, regardless of when you purchased a Dexcom G6 or G7 monitor or sensor, if you or someone in your family suffered harm from a Dexcom continuous glucose monitor (CGM) device, including the G6 or G7 systems, you may have grounds for a personal injury lawsuit. At Wisner Baum, our experienced medical device attorneys are investigating cases involving Dexcom CGM failures, missed critical alerts, inaccurate readings, and serious skin reactions that have led to diabetic emergencies and other life-threatening complications.

Fill out our contact form or call (310) 207-3233 for a free consultation. Our firm handles these claims on contingency, which means if we don’t win, you don’t pay.

What Are Dexcom Sensors?

Dexcom G6 and G7 continuous glucose monitoring (CGM) systems are designed to help people with diabetes manage their blood glucose levels by providing data in real-time, thus avoiding the need for frequent fingerstick tests. The Dexcom G6 and G7 models have become popular choices for thousands of diabetes patients.

But despite the purported benefits, these devices have been linked to significant adverse effects, which is why there are now lawsuits against Dexcom alleging harm associated with the G6 and G7 CGMs.

Dexcom G6 System Overview

The Dexcom G6 is a continuous glucose monitoring (CGM) system approved for people with diabetes ages 2 and older. Dexcom marketed the G6 to diabetes patients as a "life-changing" device. Dexcom G6 has three main components: a small sensor inserted just beneath the skin, a wireless transmitter that attaches to the sensor, and a display device such as a smartphone app or dedicated receiver.

Key Features

• 10-day sensor wear time
• Real-time glucose readings every 5 minutes
• No routine fingerstick calibrations required
• Water-resistant design for up to 8 feet underwater
• Customizable high and low glucose alerts

Dexcom G7 System Overview

The Dexcom G7 represents Dexcom's newest generation CGM technology, featuring an all-in-one wearable sensor with a pre-attached transmitter. Dexcom marketed its G7 device as the most accurate CGM cleared by the FDA.

Key Features

• 30-minute warm-up time (2x faster than competitors)
• All-in-one sensor design
• Enhanced Bluetooth connectivity
• Predictive "Urgent Low Soon" alerts
• Direct Apple Watch connectivity
• Recently approved 15-day extended wear version

How Do Dexcom CGM Sensors Work?

Both the G6 and G7 systems use a tiny sensor that measures glucose levels in interstitial fluid—the fluid between cells just under the skin. The sensor wirelessly transmits readings to display devices, allowing users to track glucose trends, receive alerts for dangerous highs and lows, and make informed diabetes management decisions without routine finger stick testing.

The Problem?

The U.S. Food and Drug Administration (FDA) discovered that Dexcom had been manufacturing G7 devices with modified sensor components since December 13, 2023, without required FDA approval. Internal clinical studies showed these unauthorized components had "significantly greater variability" than approved sensors—meaning less reliable readings during critical glucose events.

The devices are supposed to transmit readings every 5 minutes and sound alarms when glucose levels become dangerously high or low. However, the documented failures create a deadly scenario:

• Patients stop checking blood glucose manually, trusting the CGM completely.
• Defective speakers fail to alert during hypoglycemic emergencies.
• Inaccurate sensors provide false readings during critical moments.
• Patients experience seizures, loss of consciousness, and diabetic comas without warning.

The FDA issued Dexcom Class I recalls on these devices—the most serious category reserved for devices that pose a reasonable probability of serious adverse health consequences or death.

Why is There a Lawsuit Against Dexcom?

In March 2025, the U.S. Food and Drug Administration (FDA) issued a formal warning letter to Dexcom citing multiple serious violations in the manufacturing of G6 and G7 continuous glucose monitors. The FDA found that Dexcom's devices were "adulterated" due to quality system failures and unauthorized device modifications that increased the risk of inaccurate readings—potentially life-threatening for diabetes patients who rely on these devices for insulin dosing decisions.

According to the FDA, Dexcom made unauthorized changes to a critical sensor component without required FDA approval. Additionally, Dexcom conducted clinical studies that showed sensors with the new component had "significantly greater variability" than the approved sensors. The FDA stated:

“The larger inaccuracies in (b)(4)-coated sensors cause higher risks for users who rely on the sensors to dose insulin or make other diabetes treatment decisions. Therefore, we do not agree your firm has shown equivalency between (b)(4) and (b)(4) to justify that such a change does not require a new premarket submission. The variability differences could significantly affect the safety or effectiveness of the device within the meaning of 21 CFR 807.81(a)(3).

(Note: (b)(4) is FDA shorthand for "Exemption 4" under the Freedom of Information Act (FOIA), indicating the agency has redacted confidential commercial information, trade secrets, or proprietary data to protect the company's competitive interests)

Class action attorneys allege Dexcom sold consumers a product that should not have been available for sale in the market as an FDA cleared device, which was inferior in quality to the product as warranted, advertised and marketed by Dexcom. In other words, Dexcom allegedly misled consumers into purchasing G6 and G7 Continuous Glucose Monitoring System Receivers that did not meet their expectations, and as such, are not as valuable as the prices consumers paid for them.

What Did the FDA Find in the Dexcom Investigation?

Here is what the agency reported in its warning letter:

Unauthorized Device Changes: Dexcom made significant modifications to a critical sensor component without FDA approval. Sensors with the new component showed reduced accuracy and greater variability. Dexcom ceased distribution of G7 sensors with this component, but its response did not fully address affected G6 sensors.

Manufacturing Control Failures: Inadequate monitoring of glucose and acetaminophen concentrations during manufacturing processes.

Design Validation Problems: Failed to properly validate test methods and establish adequate acceptance criteria for device performance.

Risk Analysis Deficiencies: Incomplete risk assessments, particularly for devices used with automated insulin dosing systems.

Quality System Violations: Multiple failures to comply with required manufacturing standards and good manufacturing practices.

Dexcom Class Action Lawsuit Alleges Unfair, Unlawful, and Fraudulent Marketing

Class action attorneys allege Dexcom extensively marketed its G6 and G7 devices as providing accurate, reliable glucose monitoring. Lawyers say Dexcom made the following statements in its marketing:

“The Dexcom G6 Continuous Glucose Monitoring (CGM) System sends real-time glucose readings automatically to a compatible smart device or Dexcom receiver. No fingersticks, no scanning. It is proven to lower A1C, and features a 10-day sensor that is easy to use.”

“With an overall MARD of 8.2%, Dexcom G7 is the most accurate CGM cleared by the FDA.”

“The more accurate your CGM readings, the clearer the picture you get of what's happening in your body. Having accurate readings is extremely important when you depend on readings to make diabetes management decisions.”

However, according to the FDA, Dexcom devices sold to consumers were made with unapproved materials that resulted in less accurate readings than claimed in marketing materials.

Is There a Dexcom Recall?

Yes. There have been multiple recalls in 2025 affecting the Dexcom G6 and G7 devices.

Current Class I Recall — G6 & G7 Receivers (May 2025 - Ongoing)

The FDA issued a Class I recall—the most serious type—for Dexcom G6 and G7 receivers due to speaker malfunctions that prevent users from hearing critical glucose alerts. This defect can lead to life-threatening diabetic emergencies.

According to the Dexcom recall announcement, defective foam or assembly errors cause speakers to lose contact with circuit boards, silencing dangerous blood sugar alerts.

Recalled Dexcom G6 Models: STK-FM-001, STK-FR-001 (Part Number MT27408-1)

Recalled Dexcom G7 Models: STK-AT-011, STK-AT-012, STK-AT-013, STK-GT-001, STK-GT-008, STK-GT-013, STK-GT-019, STK-GT-100, STK-GT-109, STK-GT-113 (Part Numbers MT26403-0, MT26403-1, MT26403-2, MT26403-3, MT26403-4, MT26403-5)

Risk Level: Class I, which means “reasonable probability of serious adverse health consequences or death.”

Injuries Reported: At least 56 severe adverse events globally, including seizures, loss of consciousness, vomiting, and hypoglycemic/hyperglycemic symptoms. No deaths have been reported.

Total Recall Scope: Over 600,000 devices affected worldwide (602,445 G7 units globally, 36,800+ G6 units).

Health Risks Include:

• Severe hypoglycemia or hyperglycemia
• Seizures and loss of consciousness
• Potential death in worst-case scenarios

Check Your Dexcom CGM Device: Visit dexcom.com/checkreceiver or call 1-844-478-1600 for more information.

Other Dexcom Recalls

In January 2025, Dexcom issued a recall for its G6 touchscreen receivers (models with .NET operating system) due to software design flaws causing delayed or missed glucose alerts. Software updates were provided to resolve this issue.

Pattern of Safety Issues

The 2025 recalls follow previous Class I recalls in 2019 for similar G6 receiver alarm failures, demonstrating a recurring pattern of safety defects in Dexcom's alert systems. This checkered safety history of multiple device recalls strengthens legal claims for users who suffered harm from device failures.

Types of Dexcom CGM Injuries and Complications

Dexcom continuous glucose monitor failures and defects have been linked to numerous serious injuries and complications, including:

Critical Alert Failures

Missed Low Glucose Alarms: Device failures that prevent users from receiving critical hypoglycemic alerts, leading to diabetic emergencies.

False High/Low Readings: Inaccurate glucose measurements that result in inappropriate insulin dosing.

Complete System Malfunctions: Total device failures during critical monitoring periods.

Possible Physical Injuries

Severe Allergic Reactions: Painful skin reactions, blistering, and scarring at sensor insertion sites.

Diabetic Ketoacidosis (DKA): A life-threatening condition resulting from missed high glucose alerts.

Hypoglycemic Seizures: Dangerous low blood sugar episodes when devices fail to alert users.

Hospitalization: Emergency medical treatment required due to device failures.

Possible Long-Term Complications

Diabetic Complications: Worsened diabetes control due to unreliable device performance.

Psychological Trauma: Anxiety and fear related to device reliability and diabetes management.

Who Can File a Dexcom CGM Lawsuit?

You may qualify for a Dexcom lawsuit if you experienced severe medical emergencies, such as hospitalization, seizures, diabetic coma, or permanent injury, directly linked to the Dexcom G6 or G7 Continuous Glucose Monitoring System. Legal cases also focus on consumers who purchased devices that were not manufactured according to FDA-approved specifications.

The Dexcom class action lawsuit focuses on consumers who purchased G6 or G7 devices that contained sensors made with unapproved materials different from those cleared by the FDA. These consumers may not have received the product they believed they were purchasing. You can file a lawsuit even if you were not physically injured if you purchased a Dexcom G7 device or sensor during the January to November 2024 timeframe.

If you own a recalled G6 or G7 receiver and suffered harm due to missed alerts, you may have a particularly strong claim given the FDA's Class I designation and documented injury pattern.

Additional Dexcom lawsuit eligibility factors may include:

• Users who experienced seizures, loss of consciousness, or hospitalization due to missed glucose alerts.
• Individuals who suffered hypoglycemic or hyperglycemic emergencies when their receiver failed to sound alerts.
• Patients who incurred medical expenses treating complications from device failures.
• Family members of patients who suffered severe injuries from recalled devices.

Legal Basis for Dexcom Lawsuits

Wisner Baum is investigating potential Dexcom device lawsuits based on multiple legal theories, including breach of express and implied warranties, violations of consumer protection laws, and the federal Magnuson-Moss Warranty Act (MMWA). Dexcom lawsuit allegations may include:

Breach of Express Warranties

Dexcom explicitly warranted that its G6 and G7 devices were "FDA cleared" and "capable of providing accurate continuous blood glucose monitoring." However, the FDA found that devices sold to consumers contained unapproved materials that made them less accurate than claimed.

Breach of Implied Warranties

By representing that devices were FDA cleared, Dexcom implicitly warranted that they were manufactured according to FDA-approved specifications and were of the same quality as devices tested in clinical studies. The FDA warning letter contradicts these warranties.

Design Defects

When a device's design creates unreasonable risk, such as:

• Malfunctioning alert systems
• Adhesive or sensor prone to severe allergic reaction
• Sensor designs with higher failure or error rates

Manufacturing Defects

When devices deviate from design due to errors or lapses:

• Poor calibration or quality control
• Faulty sensor coatings or materials not validated by FDA
• Speaker assembly errors causing missed critical alerts

Failure to Warn

When users and doctors weren't adequately informed:

• Risks of severe skin reactions
• Alert or sensor error probabilities
• Proper device use instructions
• Known speaker defects that could prevent life-saving alerts

Regulatory Violations

Multiple Dexcom recalls combined with FDA warning letters create particularly strong evidence of regulatory non-compliance and safety failures. The pattern of recurring alert system defects across different G6 and G7 receiver models demonstrates ongoing design and manufacturing issues.

FDA warning letters, especially the March 2025 Dexcom letter, may support personal injury claims by demonstrating lapses in required notification, approval processes, and manufacturing standards.

Possible Compensation in Dexcom Lawsuits

The following damages may be awarded in personal injury claims:

Economic Damages

• Medical expenses (hospitalizations, treatments, ongoing care)
• Lost income or earning capacity due to injury
• Out-of-pocket device and replacement costs
• Full refund of purchase prices or difference between devices as marketed versus actual quality

Non-Economic Damages

• Pain and suffering (physical and emotional)
• Loss of quality of life or daily function
• Anxiety, trauma, or lasting psychological impacts
• Scarring/disfigurement

Why Choose Wisner Baum?

The medical device lawyers at Wisner Baum have a proven track record of success in complex litigation, including cases against major medical device manufacturers. Some of the reasons clients choose us include:

• Over $4 billion recovered for injury victims (across all practice areas)
• 40+ years leading complex medical device litigation
• Free consultations — no fees unless we win your case
• Compassionate, national representation for families
• Advocates for patient safety outside the courtroom
• Currently investigating Dexcom class action claims on behalf of consumers nationwide

Start your claim today by filling out our contact form or calling (310) 207-3233 for a free case evaluation.