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Early Alert: Insulin Pump Issue from Insulet
The FDA is aware that Insulet has issued a letter to affected customers recommending certain Omnipod Pods be removed from where they are used or sold. Affected devices:
- Omnipod 5 Automated Insulin Delivery System
- Omnipod DASH Insulin Management System
- Omnipod Insulin Management System (Omnipod Eros)
Insulet identified that some Pods from specific lots may have a small tear in the tubing (cannula) just above the skin, between the Pod and the point where the cannula enters the body. If this occurs, insulin may leak outside of the Pod instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin. If you are using an affected Pod, you may notice wetness on your skin or Pod adhesive or detect the smell of insulin. However, in some cases, this may be difficult to detect and may go unnoticed.
This Early Alert is for a new issue and is separate from Insulet’s removal of certain Omnipod 5 Pods initially communicated on March 12, 2026.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Insulet at https://www.omnipod.com/current-podders or call 1-800-641-2049.
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