Insulet said on Tuesday that it is voluntarily correcting certain insulin pump pods within its Omnipod product lines after discovering a manufacturing issue that could cause some patients to receive lower-than-intended insulin doses.
Following the announcement, shares of the medical device company dropped 8% in extended trading.
- The action impacts certain lots of Omnipod 5, Omnipod DASH, and the Omnipod Insulin Management System sold in the U.S. and select international markets. The issue, discovered during routine monitoring, may cause a small tear in the cannula tubing above the skin, potentially resulting in insulin leaking instead of being completely delivered.
- Patients may notice wetness or an insulin smell, although the defect could also remain unnoticed. Insulin under-delivery may lead to high blood sugar and, in severe cases, diabetic ketoacidosis, a potentially life-threatening condition.
- Insulet said in a regulatory filing that the action is separate from a March 2026 correction and is tied to a different manufacturing process, although both cases involved cannula handling at the company’s Massachusetts facility.
- Around 7 million pods are included in the current action, with nearly 60% already used or expired, representing roughly 8.5% of global pod production in 2025, according to the company.
- Insulet reported 24 serious adverse events, including hospitalizations, but no deaths. The company said it does not expect supply disruptions and estimates related costs of up to $50 million this year.
