Insulet has recalled specific lots of its insulin pods in the United States after discovering a manufacturing defect that could prevent diabetic users from receiving their full dose of the blood sugar-regulating hormone, the medical device maker said on Thursday.
The company’s shares dropped by over 7% in extended trading.
Insulet stated that a small tear in the internal tubing could result in insulin leaking inside the device instead of entering the body.
This could lead to high blood sugar levels and, in severe cases, a dangerous condition where the body starts breaking down fats too quickly, requiring emergency medical care, Insulet said.
The affected product, the Omnipod 5, is an automated insulin delivery system that attaches to the skin and administers insulin to diabetics.
Insulet has received 18 reports of serious adverse events, including hospitalizations. No deaths have been reported.
The company stated that only specific lots were affected and that all other devices in the range could be safely used.
The U.S. Food and Drug Administration has been informed of the issue, the company said.
