Medical Device Correction for Omnipod 5 Pods

On March 12, 2026, Insulet Corporation initiated a voluntary medical device correction of certain Omnipod^® 5 Pods. The action was prompted by a manufacturing issue in which some Pods from specific lots may have a small tear in the internal insulin‑delivery tubing, potentially resulting in under‑delivery of insulin. In medically significant cases, this may lead to hyperglycemia and diabetic ketoacidosis (DKA). Insulet reported 18 serious adverse events, including hospitalizations and DKA, and no deaths have been reported. Omnipod 5 is an automated insulin delivery system used for continuous subcutaneous insulin infusion in individuals with diabetes. The medical device correction is limited to specific lots distributed in the US. For more information, see here.