Omnipod Recall Lawsuit

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Investigating Claims Involving Recalled Omnipod Insulin Delivery Pods

Sullivan Papain is investigating potential claims involving certain recalled Omnipod® insulin delivery pods manufactured by Insulet Corporation. According to a voluntary Medical Device Correction announced by Insulet and published by the FDA, certain lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods may contain a manufacturing defect that can result in insulin under-delivery.

For individuals living with diabetes, proper insulin delivery is critical. When insulin is not delivered as intended, blood glucose levels can rise rapidly and, in severe cases, lead to diabetic ketoacidosis (DKA), hospitalization, or other serious complications. The recall affects millions of pods distributed throughout the United States and internationally.

If you or a loved one experienced high blood sugar, diabetic ketoacidosis, hospitalization, or other complications while using an affected Omnipod device, you may have legal rights.

What Is the Omnipod Recall About?

Insulet identified a manufacturing issue involving a small tear in the pod's tubing (cannula) that may allow insulin to leak rather than being delivered into the body. The defect can be difficult to detect and may occur without obvious warning signs. Some users have reported wetness around the pod, insulin odor, unexplained high blood glucose levels, or unexpected insulin delivery failures.

The company reported multiple serious adverse events associated with the issue, including hospitalizations and cases of diabetic ketoacidosis. Regulatory agencies, including the FDA, have been notified of the correction.

 

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Medical device for glucose check. Continuous glucose monitoring pod. Modern wireless technology in medicine.

Potential Risks Associated With Defective Omnipod Devices

Patients who experience insulin under-delivery may face serious health consequences, including:

  • Severe hyperglycemia (high blood sugar)
  • Diabetic ketoacidosis (DKA)
  • Emergency room visits
  • Hospitalization
  • Loss of work or income
  • Additional medical expenses
  • Long-term diabetes-related complications

Individuals with Type 1 diabetes, children, and others who rely on continuous insulin therapy may be particularly vulnerable to these complications.

Who May Qualify for an Omnipod Recall Lawsuit?

You may be eligible to pursue a claim if:

  • You used an Omnipod® 5, Omnipod DASH®, or Omnipod Eros pod included in the recall or medical device correction;
  • The device failed to properly deliver insulin;
  • You experienced high blood sugar, diabetic ketoacidosis, hospitalization, or another serious medical complication; and
  • You suffered damages related to medical treatment, lost wages, pain and suffering, or other losses.

Every case is unique, and eligibility will depend on the specific facts and circumstances involved.

How Sullivan Papain Can Help

For decades, Sullivan Papain has represented individuals harmed by defective products, dangerous medical devices, and corporate negligence. Our attorneys are actively monitoring developments related to the Omnipod recall and evaluating potential claims on behalf of affected patients and families.

We understand the physical, emotional, and financial burdens that can result when a medical device does not perform as intended. Our team is committed to helping injured individuals understand their legal options and pursue the compensation they may deserve.

Contact Sullivan Papain

If you or a loved one experienced complications while using a recalled Omnipod device, contact Sullivan Papain today for a free, confidential case evaluation.

Our attorneys can review your circumstances, answer your questions, and help determine whether you may have a claim related to the Omnipod recall.