Insulet has sent out a voluntary medical device correction notice for a series of its Omnipod devices amid a manufacturing fault that could lead to insulin leaking and not being fully delivered.
This notice is for specific lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros) Pods.
In a Securities and Exchange Commission (SEC) filing, Insulet said it “expects to incur up to $50 million of costs associated with this correction in 2026.”
During an inspection, Insulet found some Pods from specific lots “may have a small tear in the tubing (cannula) just above the skin, between the Pod and the point where the cannula enters the body,” the company said.
This can cause insulin to leak outside of the Pod. If a full dose of insulin is not delivered to diabetes patients, it can cause serious health issues from higher blood glucose levels.
This is a separate issue from the voluntary correction the company sent out in March, Insulet said. That was for specific Omnipod 5 Pods.
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Around 7 million Pods “are included within the scope of this action,” with more than half (around 60%) of which “have been consumed or are expired,” according to the company.
This is around 8.5% of its 2025 global Omnipod Pod production. “Globally, there have been 24 reports of serious adverse events associated with high blood glucose levels, including hospitalization,” the company said, but no reported deaths.
It said it has now corrected the manufacturing issue.
