Insulet has issued a critical recall affecting specific lots of Omnipod 5 and Omnipod DASH Pods after identifying a manufacturing issue through routine product monitoring.

The issue relates to a small tear that may occur in the Pod’s cannula (tubing), just above the skin. If this happens, insulin may leak outside the Pod instead of being fully delivered into the body, which can result in less insulin being delivered than intended.

People using an affected Pod may notice signs such as moisture on the skin or Pod adhesive, or the smell of insulin. However, in some cases, the leak may not be obvious. This means blood glucose levels may rise and may not respond as expected to insulin delivery. While users of Omnipod 5 in Automated Mode may receive an alert, this issue can also occur without any notification, so it’s important not to rely solely on Pod alerts.

Affected lots include:

• Omnipod^® 5: PH1U10212421
• Omnipod DASH^®: PD1U09042421, PD1U11122421, PD1U11202421

Reduced insulin delivery can lead to high blood glucose levels (hyperglycaemia). In more serious cases, prolonged high blood glucose can lead to diabetic ketoacidosis (DKA), a life-threatening condition that requires urgent medical treatment. Globally, there have been 24 reports of serious adverse events, including hospitalisation and DKA. There have been no reported deaths and no serious adverse events reported in Australia.

This issue does not affect continuous glucose monitoring (CGM) systems or CGM readings.

Insulet has identified the cause of the problem and implemented corrective actions. Pods that are not included in the affected lots remain safe to use, and supply is not expected to be disrupted.

Impacted customers are being contacted directly with instructions on how to check lot numbers, stop using affected Pods, and arrange free replacements. If you think your Pods may be affected, stop using them immediately and switch to a Pod from an unaffected lot.

For support, contact Insulet Product Support on 1800 954 074 (available 24/7), or speak with your healthcare professional.