Check your device ASAP.
Key Points
- Insulet is recalling Omnipod insulin pumps due to a defect that may cause insulin under-delivery.
- Affected users may notice insulin leaks, which could lead to high blood glucose or serious complications.
- Check your pod’s lot code online to see if it’s affected, and request free replacements if necessary.
A popular insulin management system is being voluntarily recalled by the company due to a manufacturing issue that could result in the under-delivery of insulin, the U.S. Food and Drug Administration announced.
Insulet Corporation announced that select batches of their Omnipod® 5, Omnipod DASH® and Omnipod® Insulin Management System (Omnipod Eros) pods may have a small tear—possibly resulting in the leaking or under-delivery of insulin to the user.
The manufacturing issue is currently affecting 7 million pods, approximately 60% of which have already been used or have reached their expiration date.
To check whether their device is affected, Insulet recommends that consumers visit their check pof lot page and enter the lot code that is printed on the tray lid of the Pod. If your product is affected, Insulet says to discontinue use and request free replacements.
Upon the use of an affected pod, users may detect wetness on their skin or the smell of insulin—a result of the insulin leaking from the device and failing to correctly enter the body. There is also the possibility that any signs of a defect may go unnoticed.
Either way, the misuse of these devices may result in high blood glucose levels, which may lead to diabetic ketoacidosis (DKA), a serious and life-threatening condition that requires medical treatment.
U.S. customers in need of assistance can contact Insulet Product Support at 1-800-641-2049, or use talk to an agent through the Omnipod website.
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