Insulin devices recalled over leak risk, reports of 'serious adverse events'

Insulet Corporation has issued a voluntary recall of certain insulin pods that may have a tear in the tubing and fail to fully deliver insulin to the body. 

The recall comes after 18 reports of "serious adverse events." Here’s the latest:

Insulet Omnipod 5 Pods recall

What we know:

The recall involves specific lots of Omnipod 5 Pods, which are "tubeless automated insulin delivery" devices, according to the Omnipod website. 

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According to Insulet, the company that makes them, some of the pods "may have a small tear in the internal tubing that delivers insulin."

What we don't know:

It's unclear how many pods have been recalled, but Insulet says it's about 1.5% of its total annual production. 

What they're saying:

"If this occurs, insulin may leak inside the Pod instead of being fully infused into the body as intended," the company says. "If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment."

Why you should care:

Insulet says it has received 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. No deaths have been reported.

What you can do:

Customers are urged to visit this website to confirm whether their Pod lot number is included in the recall, then request a free replacement. 

"If there is a fluid leak inside the Pod, you may receive a hazard alarm to notify you to remove your Pod," Insulet says. "It is important that you change your Pod immediately to resume full insulin delivery. When changing your Pod, confirm the new Pod is not from an affected lot. This risk of under-delivery increases if you use more than one affected Pod in a row.

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"It is important that you check the lot number on  your  Pod tray lid, the Pod box or the Pod itself to determine if your Pods are affected," the company says. "There may be multiple Pods from impacted lots within the same box. You should not use any Pods from the identified lots."

Customers can contact Insulet Product Support at 1-800-641-2049 (available 24/7) or use the live agent chat for more assistance.