The U.S. Food and Drug Administration (FDA) has classified Insulet Corporation’s recall of certain Omnipod insulin delivery pods as a Class I recall, the agency’s most serious designation. The FDA warned that continued use of affected devices could result in serious injury or death because some pods may fail to deliver the intended amount of insulin.
The recall affects specific production lots used with the Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System, and the Omnipod Insulin Management System, also known as Omnipod Eros.
People using the affected devices are being instructed to stop using pods from impacted lots and replace any affected pod currently in use. According to the FDA, users who do not have enough replacement pods should consult their healthcare provider about alternative methods of insulin delivery while waiting for replacements.
The FDA said the issue is linked to a manufacturing defect that can reduce insulin delivery without always producing a device alert. As a result, users are being advised not to rely solely on automated warnings to detect the problem.
Manufacturing Defect May Reduce Insulin Delivery
According to the FDA, Insulet identified that certain pods from specific production lots may contain a small tear in the cannula tubing located just above the skin, between the pod and the point where the cannula enters the body. If the tubing is damaged, insulin may leak outside the body instead of being delivered as intended, resulting in under-delivery of insulin.
Some users may notice wetness on the skin or pod adhesive or detect the smell of insulin, although the company noted that leaks may also go unnoticed. The FDA stated that even when the Omnipod 5 system is operating in Automated Mode, the problem may occur without triggering an Automated Delivery Restriction alert.
Insulet instructed customers to verify the lot number printed on the pod tray lid, pod box, or pod itself and compare it with the list of affected lots. The company also advised users to discontinue use of impacted pods immediately, request replacements through its customer notification process, and return unused affected pods using a provided return kit.
The FDA also reminded users to check expiration dates before using any pod and to follow their healthcare provider’s guidance on glucose monitoring if replacement devices are not immediately available.
FDA Warns of Serious Health Risks From Under-Delivery of Insulin
According to the FDA, insufficient insulin delivery may cause blood glucose levels to rise and fail to respond as expected to insulin therapy. If elevated blood glucose persists, it can progress to diabetic ketoacidosis, a serious condition that requires prompt medical treatment and may become life-threatening if left untreated.
The agency emphasized that the issue does not affect continuous glucose monitoring systems or the accuracy of glucose monitoring readings. The concern is limited to insulin delivery from certain Omnipod pods included in the recall.
As of May 20, Insulet had reported 24 serious injuries associated with the issue and no deaths, according to information released by the FDA. The agency updated its public communication on July 2 to announce that the corrective action had been formally classified as a Class I recall, following an earlier safety alert issued on June 4.
The FDA said the recall involves removing affected devices from where they are used or sold. Customers experiencing quality issues or adverse reactions are encouraged to contact Insulet’s product support service or report problems through the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
