The U.S. Food and Drug Administration (FDA) has designated Insulet Corp.’s (NASDAQ:PODD) recall of certain Omnipod insulin delivery pods as a Class I recall, the agency’s most serious classification, warning that continued use of affected devices could result in serious injury or death.
The recall follows concerns that some pods may fail to deliver the intended amount of insulin, increasing the risk of dangerously high blood sugar levels and diabetic ketoacidosis (DKA).
Omnipod devices deliver insulin subcutaneously at programmed and variable rates for people with diabetes who require insulin therapy.
FDA Urges Users To Stop Using Affected Pods
The FDA said on Thursday the recall calls for removing specific Omnipod pods from where they are used or sold.
The affected products include the Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System and Omnipod Insulin Management System (Omnipod Eros).
The company advises customers not to use pods from affected lots and to inspect the lot number printed on the pod tray lid, pod box or pod itself.
If a user is currently wearing an affected pod, the FDA recommends replacing it immediately with one from an unaffected lot to restore insulin delivery.
Users who have depleted their supply because of the recall should consult their health care provider about alternative insulin delivery methods while awaiting replacements.
Cannula Defect May Cause Insulin Leakage
Insulet identified that certain pods from specific production lots may contain a small tear in the cannula tubing located just above the skin.
The defect can allow insulin to leak outside the body instead of being fully delivered, potentially resulting in insufficient insulin administration.
Affected users may notice wetness around the pod or smell insulin, although the leak may also go undetected.
The FDA cautioned that even users of the Omnipod 5 system operating in automated mode should not rely solely on device alerts, as the issue may occur without triggering a warning.
Risk Of High Blood Sugar and DKA
Insulin under-delivery can lead to elevated blood glucose levels that may not respond as expected to insulin therapy.
In severe cases, prolonged high blood sugar can progress to diabetic ketoacidosis, a potentially life-threatening condition requiring prompt medical treatment.
The FDA noted that the issue does not affect continuous glucose monitoring systems (CGM) readings.
As of May 20, Insulet had reported 24 serious injuries associated with the issue and no deaths.
PODD Stock Price Activity: Insulet shares were down 3.30% at $159.05 at the time of publication on Monday, according to Benzinga Pro data.
Image via Insulet
