Insulet Corporation is recalling 1,240,115 Omnipod 5 Pods because a manufacturing defect can cause an internal tear in the cannula. This tear leads to insulin leaking inside the device rather than being delivered to the user, regardless of whether it is a basal or bolus dose. The defect has affected 49 specific lots of the product.
Leaking insulin can cause severe under-delivery or a total stop in delivery if the leaked fluid shorts the device's circuitry, leading to dangerously high blood sugar (hyperglycemia). This poses a risk for diabetic ketoacidosis (DKA), hospitalization, and potentially death.
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Affected pods are from 49 specific lots; 36 codes were explicitly listed in the notification text.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · FDA Press Release · Raw API Response
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