FDA announces recall of insulin delivery pods
Insulet Corporation has announced a voluntary recall for specific lots of the pods associated with its Omnipod 5 Automated Insulin Delivery System. Due to an issue with the manufacturing process, the company explained, there is a risk of some pods being damaged.
“Insulet identified that certain pods from specific lots may have a small tear in the internal tubing that delivers insulin,” according to a new advisory shared by the U.S. Food and Drug Administration (FDA). “If this occurs, insulin may leak inside the pod instead of being fully infused into the body as intended. 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, a serious medical condition that requires prompt medical treatment.”
A total of 18 serious adverse events related to high blood glucose levels have been linked to this manufacturing issue. Insulet emphasized that the problem has already been corrected; no other pods should experience these tears going forward. The company also noted that the Omnipod 5’s continuous glucose monitoring (CGM) capabilities were not affected by the issue
“Patient safety and product quality remain Insulet’s highest priorities,” according to the advisory.
Customers can visit this link to see if their pods are part of the voluntary recall.
Additional context about the Omnipod 5 technology
The Omnipod 5 Automated Insulin Delivery System, cleared by the FDA for treating patients with both type 1 and type 2 diabetes, includes a pod and CGM sensor that are in constant communication. It was built to provide automated insulin delivery for up to three days without requiring daily injections. Users access these tools using the Omnipod 5 smartphone app.
The pods are filled with up to 200 units of U-100 rapid-acting insulin and placed directly on the skin. They were built to be waterproof and can be worn under clothing.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.