Insulet Recalls Omnipod Pods After Insulin-Delivery Failure Risk Identified, FDA Says

MT Newswires Live07-03

Insulet (PODD) has recalled certain Omnipod pods after identifying a defect that could affect insulin delivery, the US Food and Drug Administration said Thursday.

The recall includes specific pods used in the Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System, and Omnipod Insulin Management System (Omnipod Eros). Insulet has instructed affected customers to remove pods from use or sale, the regulator said.

The FDA classified the action as a Class I recall, its most serious type, because continued use may lead to serious injury or death.

Insulet found that pods from certain lots may have a small tear in the cannula, the tubing that delivers insulin under the skin. As of May 20, the company reported 24 serious injuries and no deaths linked to the issue, the FDA said.

On May 26, Insulet initiated a voluntary medical device correction for the products.

Insulet didn't immediately reply to a request for comment from MT Newswires.

Price: 165.55, Change: +5.76, Percent Change: +3.60

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