The U.S. Food and Drug Administration (FDA) has classified a recall of Insulet Corporation's (NASDAQ:PODD) Omnipod 5 Pods as its most serious type, warning that continued use of affected devices could result in severe injury or death.
FDA Labels Omnipod 5 Recall As Most Serious
The recall involves removing certain devices from use due to a defect that may compromise insulin delivery.
The agency's designation underscores concerns that patients relying on the device for diabetes management may face significant health risks if impacted units are not promptly discontinued.
Injury Reports And Device Use
The company reported 476 serious injuries associated with the issue, though no deaths have been recorded.
The Omnipod system is designed for subcutaneous insulin delivery at programmed intervals, supporting diabetes management in patients requiring insulin therapy.
The current issue does not affect continuous glucose monitoring systems or their readings.
Expanded Recall And Customer Guidance
In April, Insulet expanded the list of affected product lots and issued updated guidance to users. The company indicated that the defect—potentially undetectable by users—could occur without triggering alarms.
Customers were instructed not to use pods from affected lots and to immediately switch to unaffected units.
Those lacking sufficient supply are advised to consult healthcare providers for alternative insulin delivery methods. The company has also urged users to verify lot numbers and request replacements.
Defect May Cause Insulin Under-Delivery
According to the company, certain pods may contain a small tear in the internal tubing responsible for insulin delivery. This flaw can lead to insulin leaking from the device rather than being fully delivered to the body.
Such under-delivery can result in elevated blood glucose levels.
In severe cases, prolonged hyperglycemia may lead to diabetic ketoacidosis, a potentially life-threatening condition requiring urgent medical intervention.
Risks May Go Undetected
While some users may receive hazard alerts indicating a fluid leak, the issue can also occur without any warning. This increases the risk of patients unknowingly receiving insufficient insulin.
The likelihood of complications may rise if multiple affected pods are used consecutively. Health authorities caution users against relying solely on device alarms and recommend proactive monitoring and prompt replacement of affected units.
PODD Price Action: Insulet shares were down 10.95% at $162.84 at the time of publication on Wednesday. The stock is trading at a new 52-week low, according to Benzinga Pro data.
Image: Insulet
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