FDA Aware of Insulet Product Defect Leading to 24 Serious Injuries
The FDA said it is aware that Insulet issued a letter to affected customers recommending certain Omnipod Pods be removed from where they are used or sold. The affected devices are Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System, and Omnipod Insulin Management System. Insulet identified that some Pods from specific lots may have a small tear in the tubing just above the skin, between the Pod and the point where the cannula enters the body. As of May 20, Insulet reported 24 serious injuries and no deaths associated with this issue.