Insulet Omnipod DASH Pod recalled for insulin leakage risk during manufacturing
What this means
Some Omnipod DASH Pods have a manufacturing defect in the soft cannula (the tiny tube that delivers insulin) that can cause insulin to leak around the pod instead of into your body. This means you may receive less insulin than needed, which can lead to high blood sugar levels.
- Check your pod lot number against the FDA recall list at insulet.com or fda.gov.
- If your pod matches a recalled lot, contact Insulet at 1-800-591-3455 for a replacement.
- Monitor your blood sugar closely and watch for signs of high glucose or ketoacidosis (nausea, vomiting, fruity-smelling breath, shortness of breath).
- If you experience symptoms of high blood sugar or ketoacidosis, seek immediate medical attention.
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-2604-2026More Insulet recalls
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