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# FDA Warns of Potentially High-Risk Issue With Insulet Insulin Pumps
- URL: https://www.fdaweb.com/fda-warns-of-potentially-high-risk-issue-with-insulet-insulin-pumps/
- Published: 2026-03-18T12:00:00.000Z
- Updated: 2026-09-14T13:35:42.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160843

FDA has issued an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet, citing risks of improper insulin delivery. The [alert](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-insulin-pump-issue-insulet?utm%5Fmedium=email&utm%5Fsource=govdelivery) applies to specific lots of the company’s Omnipod 5 Pods, a tubeless insulin delivery system used by people with diabetes. The FDA said it is continuing to evaluate the issue and will provide updates as more information becomes available. The company has reported 18 serious injuries linked to the issue.

According to the agency, some affected Pods may contain a small tear in internal tubing that delivers insulin. This defect can cause insulin to leak from the device instead of being properly infused into the patient’s body. As a result, users may receive less insulin than intended, increasing the risk of elevated blood glucose levels. In severe cases, prolonged under-delivery could lead to diabetic ketoacidosis, a potentially life-threatening complication that requires urgent medical treatment, the agency says.

Omnipod 5 Pods are widely used for the subcutaneous delivery of insulin in patients with diabetes, providing automated and adjustable dosing without the need for traditional insulin pump tubing.