Insulet Corporation has announced a voluntary Medical Device Correction for specific lots of its Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods, citing a manufacturing issue that could lead to the under-delivery of insulin.
The company identified that some Pods may have a small tear in the tubing (cannula), causing insulin to leak externally instead of being fully delivered. Users might notice wetness on their skin or Pod adhesive, or detect the smell of insulin, though the issue can also go undetected. This under-delivery can result in high blood glucose levels, and in severe cases, prolonged high blood glucose can lead to diabetic ketoacidosis (DKA), a serious and potentially life-threatening condition.
Approximately 7 million Pods are included in this action, with about 60% already consumed or expired. These affected Pods represent about 8.5% of Insulet's 2025 global Omnipod Pod production. Globally, 24 serious adverse events, including hospitalizations and DKA, have been reported, but no deaths. Insulet has identified the cause, implemented corrective actions, and strengthened quality controls to prevent recurrence.
Insulet is proactively contacting affected customers, providing instructions to identify impacted lots, discontinue use, and obtain free replacement Pods. The company assures sufficient supply for replacements and has notified the U.S. Food and Drug Administration (FDA) and other regulatory authorities. Customers should visit the company's dedicated website to check their Pod lot number and request replacements, or contact Insulet Product Support at 1-800-641-2049 for assistance.