Insulet Corporation Initiates Voluntary Medical Device Correction for Specific Omnipod® Pod Lots

Insulet Corporation announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue identified through ongoing product monitoring. The issue, a small tear in the cannula tubing, could lead to insulin under-delivery, potentially causing high blood glucose levels and, in severe cases, diabetic ketoacidosis (DKA). Approximately 7 million Pods are affected, with about 60% already consumed or expired. The company has received 24 reports of serious adverse events, including hospitalizations and DKA, but no deaths. Insulet has identified the cause, implemented corrective actions, and strengthened quality controls. They expect costs up to $50 million in 2026, excluding adjusted results, but do not anticipate disruption to shipments or availability. The company is proactively communicating with affected customers and regulatory authorities, including the FDA, and is providing replacements at no cost. Customers can check lot numbers and request replacements on the company's website.