Recalled Omnipod 5 Insulin Pods May Cause Life-Threatening Complications
If you or a loved one used the Omnipod 5 Insulin Delivery System, you may be at risk of suffering serious complications due to a manufacturing defect in some recently distributed units. Insulet Corporation, the manufacturer of the system, has initiated a product recall for specific lots of its Omnipod 5 Pods distributed across the United States.
At Saltz Mongeluzzi Bendesky, our team of medical device attorneys are actively investigating potential legal claims on behalf of diabetes patients who have suffered severe injuries or required hospitalization due to this failure. We believe that manufacturers have a non-negotiable duty to ensure their life-sustaining medical devices are safe before they reach consumers.
What Happened? The Omnipod 5 Defect
The company identified a manufacturing defect in certain recalled lots of its Omnipod 5 insulin patch pumps that can cause a small tear in the internal tubing that is responsible for delivering insulin from the Pod into the body. When this tear occurs, the insulin meant for the patient instead leaks inside the Pod itself. The patient may be unaware that they are not receiving their programmed dose of insulin.
The Serious Risks to Patients: DKA and Hyperglycemia
Patients with insulin-dependent diabetes can suffer catastrophic outcomes if they do not receive proper dosages of insulin. The resulting under-delivery of insulin can lead to:
- Severe Hyperglycemia: Critically high blood glucose levels.
- Diabetic Ketoacidosis (DKA): A life-threatening medical emergency where the body begins breaking down fat too fast, making the blood acidic. DKA requires immediate, often intensive, medical intervention.
- Other serious complications such as a heart attack, stroke, coma, or death.
According to initial reports, there have already been 18 serious adverse events associated with this defect, including patient hospitalizations. Symptoms of DKA include nausea, vomiting, abdominal pain, frequent urination, extreme thirst, confusion, and a fruity odor on the breath. If you experience these symptoms, seek emergency medical attention immediately.
What Should You Do Now?
- Identify Your Pods
The recall only affects specific lot numbers of Omnipod 5 Pods. You must check the lot number of your current inventory. The lot number can be found on:
- The flat side of the individual Pod
- The lid of the individual Pod tray
- The side of the 5-pack Pod box
- Discontinue Use of Affected Pods
If you identify that any of your Pods are from an affected lot, stop using them immediately. Do not attempt to use another Pod from the same box, as multiple defective units may be in a single package.
- Seek Medical Advice and Replacements
Contact your healthcare provider if you have used an affected pod or have concerns about your insulin delivery. Insulet is providing free replacement Pods to those with affected lot numbers.
Your Legal Options
If you or a loved one used an Omnipod 5 device from a recalled lot and subsequently required hospitalization or were diagnosed with Diabetic Ketoacidosis (DKA) or severe hyperglycemia, you may be eligible to file a product liability lawsuit.
How Saltz Mongeluzzi Bendesky Can Help
When a company fails to maintain rigid quality control over a product as essential as an insulin pump, they must be held accountable. We focus on product liability and medical device litigation, helping patients secure the justice and financial support they need to recover.
Please contact us today if you believe that you or a loved one was injured after using a recalled Omnipod 5 Insulin Pod.