Insulet Omnipod 5 Pods recalled for insulin leakage risk due to manufacturing defect
What this means
Some Omnipod 5 insulin pump pods have a manufacturing defect in the soft cannula (the small tube that delivers insulin) that can cause insulin to leak outside the pod instead of being delivered into the body. This under-delivery of insulin can lead to high blood sugar levels. In severe cases, prolonged high blood sugar can result in diabetic ketoacidosis or other serious complications.
- Check if your pod model and lot number match the FDA recall list (available at fda.gov).
- Contact Insulet Corporation for instructions on obtaining replacement pods.
- Monitor your blood glucose levels closely and watch for signs of high blood sugar.
- If you experience unexplained high blood sugar readings, contact your healthcare provider immediately.
The agency's original wording
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2603-2026More Insulet recalls
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