Insulet Corp. (NASDAQ:PODD) shares are down during Friday’s premarket session following the company’s announcement of a voluntary Medical Device Correction for certain lots of Omnipod 5 Pods.

Manufacturing Defect

Insulet identified a manufacturing issue affecting specific lots of Omnipod 5 Pods, which may have a small tear in the internal tubing that delivers insulin.

This could lead to under-delivery of insulin, potentially resulting in high blood glucose levels and serious medical conditions, including diabetic ketoacidosis (DKA); the company has received 18 reports of serious adverse events related to this issue.

Diabetic ketoacidosis is a life-threatening, critical metabolic emergency, primarily in type 1 diabetes, where insufficient insulin causes the body to burn fat for fuel, producing high levels of blood acids (ketones).

The affected Pods represent approximately 1.5% of annual production globally, and Insulet has assured that all other Omnipod products remain safe for use.

Insulet on Thursday noted that the issue does not affect continuous glucose monitoring (CGM) systems or ...