Insulet flags dosing defect in some Omnipod devices, sees up to $50 million cost

May 26 (Reuters) – Insulet said on Tuesday it is carrying out a voluntary correction of certain insulin pump pods across its Omnipod product lines after identifying a manufacturing issue that could result in patients receiving too little insulin.

Shares of the medical device maker fell 8% in extended trading.

Here are a few details:

• The action affects specific lots of Omnipod 5, Omnipod DASH and the Omnipod Insulin Management System distributed in the U.S. and some international markets.

• The issue, identified through routine monitoring, may cause a small tear in the cannula tubing above the skin, potentially leading to insulin leaking instead of being fully delivered.

• Patients may notice wetness or the smell of insulin, though the defect may go undetected.

• Under-delivery can lead to high blood sugar and, in severe cases, diabetic ketoacidosis, a life-threatening condition.

• The action is separate from a March 2026 correction and is linked to a different manufacturing process, though both involved cannula handling at the company’s Massachusetts facility, Insulet said in a regulatory filing.

• About 7 million pods are included in the current action, of which roughly 60% have already been used or expired, representing about 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 does not expect supply disruptions and sees up to $50 million in related costs this year.

(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)