Omnipod 5 Insulin Pump Recall Follows Reports of Serious Injuries: FDA

Agency indicates the issue stems from a potential manufacturing defect that may cause a small tear in the internal tubing responsible for delivering insulin.

Federal health officials are alerting patients and healthcare providers to a potential issue with certain Omnipod 5 insulin delivery pods, following reports that the devices may malfunction and administer inaccurate insulin doses.

The U.S. Food and Drug Administration (FDA) issued an Omnipod 5 alert earlier this week, indicating that it has received reports of 18 serious injuries associated with this issue.

Those who rely on insulin pump systems like the Omnipod 5 depend on precise, consistent dosing to manage diabetes. The Omnipod 5 is a tubeless system that uses small, wearable pods to continuously deliver insulin throughout the day, making accurate performance critical, especially for individuals with Type 1 diabetes.

According to federal regulators, a problem with certain Omnipod 5 pods may cause under-delivery or over-delivery of insulin. Because these pods control real-time insulin release, any malfunction can lead to dangerous blood sugar fluctuations. Underdelivery may result in hyperglycemia, increasing the risk of diabetic ketoacidosis, dehydration and hospitalization. Overdelivery can cause hypoglycemia, which may lead to dizziness, confusion, seizures, loss of consciousness or even death if severe and untreated.

As reports of injuries continue to emerge, attorneys are now investigating potential Omnipod 5 lawsuits for individuals who experienced serious complications, including diabetic ketoacidosis, severe hypoglycemic events, emergency room visits or other adverse health outcomes linked to malfunctioning insulin delivery pods.

Omnipod 5 Insulin Pod Recall

The current recall includes all products with unique device identifier (UDI) 10385083000527. A full list of affected lot numbers may be found in the FDA notice.

According to the FDA, the issue stems from a potential manufacturing defect that may cause a small tear in the internal tubing responsible for delivering insulin. If this occurs, insulin may leak inside the pod instead of being properly infused into the body, resulting in under-delivery and rising blood glucose levels.

Healthcare providers are being advised to closely monitor patients using the affected pods and to watch for signs of improper insulin delivery, including unexpected changes in blood glucose levels. Patients are also urged not to use pods from affected lots and to follow manufacturer guidance on identifying impacted devices. 

If a pod triggers a hazard alarm, which may indicate a delivery failure, users should remove and replace it immediately. The risk of under-delivery may increase if multiple affected pods are used consecutively.

The recall does not involve the Omnipod 5 controller, continuous glucose monitoring systems or the automated insulin delivery algorithm, but is limited to specific pods that may not function as intended. Insulet, the product manufacturer, is notifying customers and healthcare providers about steps to identify affected products, request replacements and reduce the risk of harm.

U.S. customers experiencing adverse events, product quality concerns or seeking additional information about the recall can contact Insulet at 1-800-641-2049 or access live chat support through the company website. Healthcare providers and consumers may also submit reports of adverse events or product quality issues related to these devices through MedWatch, the FDA’s safety information and reporting program.

Diabetes Device Failure Lawsuits

The Omnipod 5 warning adds to growing concerns about the safety and reliability of diabetes management devices, which have faced increasing scrutiny in recent years.

Attorneys nationwide are now investigating lawsuits involving both insulin delivery pods and continuous glucose monitors, including Omnipod 5 pods and FreeStyle Libre 3 sensors, following recalls and safety alerts tied to inaccurate insulin dosing and faulty glucose readings.

A series of FreeStyle Libre 3 lawsuits emerged over reports that defective sensors may provide inaccurate blood glucose readings, potentially leading patients to administer too much or too little insulin. When paired with issues involving insulin delivery pods like Omnipod, these failures may increase the risk of dangerous glucose mismanagement.

Individuals may be eligible to pursue a claim if they or a loved one used a recalled Omnipod 5 pod or FreeStyle Libre 3 or Libre 3 Plus sensor and experienced serious complications, including:

• Wrongful death
• Extreme hypoglycemia
• Seizures
• Confusion or altered mental status
• Loss of consciousness
• Diabetic ketoacidosis
• Other acute metabolic emergencies
• Hospitalization

Product liability lawyers provide free case evaluations to help determine whether an individual may be able to file a lawsuit to seek compensation. All claims are handled on a contingency fee basis, which means there are no fees or expenses unless a settlement is obtained in your case. 

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