Insulet flags dosing defect in some Omnipod devices, sees up to $50 million cost
Insulet Corporation PODD | 0.00 |
May 26 (Reuters) - Insulet PODD.O 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.
