Insulet Initiates Voluntary Recall of Certain Omnipod 5 Products

The company states: "Insulet initiated a voluntary Medical Device Correction for specific lots of Omnipod(R) 5 Pods after identifying a manufacturing issue through its ongoing product monitoring. This action applies to specific identified lots distributed in the United States, and all other Omnipod 5 Pods and Omnipod(R) products remain safe to use. Insulet identified that certain Pods from specific lots may have a small tear in the internal tubing that delivers insulin. If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis, a serious medical condition that requires prompt medical treatment. Insulet has received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. No deaths have been reported. This issue does not affect continuous glucose monitoring systems or CGM readings. Following its investigation, Insulet has implemented updates to its manufacturing processes and quality controls to strengthen detection and prevention and further support the integrity of its products. The Pods involved in this correction represent approximately 1.5% of annual Omnipod(R) 5 pod production globally. Insulet continues to manufacture and ship Omnipod(R) 5 Pods and does not anticipate disruption to customer shipments, product availability, or new patient starts."