Insulet Corporation has recalled certain batches of its insulin-delivery pods in the United States after identifying a manufacturing defect that could prevent diabetic patients from receiving their full dose of the blood-sugar regulating hormone, the medical device company said on Thursday.
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Following the announcement, shares of the company fell nearly 7% in extended trading.
The company said a small tear in the device’s internal tubing may cause insulin to leak inside the pod instead of being delivered into the body.
That can lead to high blood sugar levels, and in severe cases, a dangerous condition where the body starts breaking down fat too quickly that needs urgent medical care, Insulet said.
The affected product, the Omnipod 5, is an automated insulin-delivery system that attaches to the skin and delivers insulin to people with diabetes.
Insulet has received 18 reports of serious adverse events, including hospitalizations. No deaths have been reported.
It said only specific lots are affected and that all other devices in the line remain safe to use.
The U.S. Food and Drug Administration has been notified of the issue, the company said.
