ACTON, Mass. — Insulet Corporation (NASDAQ: PODD) has initiated a voluntary Medical Device Correction for specific lots of its Omnipod 5 Pods in the United States after identifying a manufacturing issue through routine product monitoring.
The company said the action applies only to certain identified lots of Omnipod 5 Pods distributed in the U.S., while all other Omnipod 5 Pods and Omnipod products remain safe for use.
According to Insulet, certain Pods from the affected lots may contain a small tear in the internal tubing that delivers insulin. If the defect occurs, insulin may leak inside the Pod instead of being fully delivered into the body as intended.
Improper insulin delivery could cause users to experience high blood glucose levels due to under-delivery of insulin. In more severe cases, prolonged high blood glucose may lead to diabetic ketoacidosis (DKA), a serious condition that requires prompt medical treatment.
The company said it has received 18 reports of serious adverse events linked to elevated blood glucose levels, including hospitalizations and cases of DKA. No deaths have been reported.
Insulet said the issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.
Customers can check whether their Pods are affected by visiting omnipod.com/check-pods to verify lot numbers and request replacement Pods at no cost.
Following an internal investigation, the company said it has implemented updates to its manufacturing processes and quality control systems to strengthen defect detection and prevention and to support product integrity.
Insulet said the affected Pods account for approximately 1.5 percent of global annual Omnipod 5 Pod production. The company continues to manufacture and ship Omnipod 5 Pods and does not expect disruptions to shipments, product availability, or new patient starts.
The U.S. Food and Drug Administration has been notified of the action, the company said, adding that patient safety and product quality remain its highest priorities.
