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Millions of Certain Omnipod Insulin Pods Recalled over Leaking Defect
Insulet is contacting customers and replacing defective pods for free after 24 serious adverse events were reported worldwide, the FDA said.
- The U.S. Food and Drug Administration recalled approximately 7 million Omnipod insulin pods due to a manufacturing defect involving small tears in pod tubing positioned just above the skin.
- Insulin leakage resulting from the tubing tears allows medication to escape the body rather than being delivered to patients, preventing them from receiving full prescribed doses.
- Globally, 24 serious adverse events including hospitalizations and diabetic ketoacidosis have been reported, while no deaths have been linked to the recall as of this report.
- Insulet Corporation is replacing all defective pods at no cost and urges consumers to stop using affected units immediately; U.S. customers can contact Insulet Product Support 24/7 at 1-800-641-2049.
- Consumers can verify recall eligibility by locating the lot number on the pod or tray lid and entering it into the online database; international customers access localized information at www.omnipod.com.
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Insulet flags dosing defect in some Omnipod devices, sees up to $50 million cost
Insulet said on Tuesday it is carrying out a voluntary correction of certain insulin pump pods across its Omnipod product lines after identifying a manufacturing issue that could result in patients receiving too little insulin.
·United Kingdom
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Insulet initiates another Omnipod 5 recall, affects Dash, Eros too
The Omnipod 5 worn on the arm. [Image courtesy of Insulet]Insulet (Nasdaq:PODD) today announced a voluntary medical device correction for specific lots of its Omnipod 5, Dash and Eros pods. The company identified a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery with the affected current-generation Omnipod 5, previous-generation Omnipod Dash or the prior Omnipod Insulin Management System (Eros).…
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