Insulet Corporation (NASDAQ: PODD) initiated a voluntary medical device correction for specific lots of Omnipod 5 Pods after identifying a manufacturing issue that could cause insulin leaks.

The company discovered that certain pods from specific lots may have a small tear in internal tubing that delivers insulin. When this occurs, insulin may leak inside the pod instead of being delivered to the user's body, potentially causing high blood glucose levels.

Insulet received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and diabetic ketoacidosis. No deaths were reported. The affected pods represent approximately 1.5% of annual Omnipod 5 pod production globally.

The correction applies only to specific lots distributed in the United States. All other Omnipod 5 pods and Omnipod products remain safe to use, according to the company. The issue does not affect continuous glucose monitoring systems or readings.

Users can check if their pods are affected by visiting omnipod.com/check-pods and can request replacement pods at no cost. Customers currently using pods from affected lots should discontinue use and replace them with pods from unaffected lots.

The Food and Drug Administration has been notified of the action. Insulet implemented updates to its manufacturing processes and quality controls following its investigation.

The company stated it continues to manufacture and ship Omnipod 5 pods and does not anticipate disruption to customer shipments, product availability, or new patient starts.