Insulet recalls 7M insulin delivery pods due to safety risk
Insulet Corp. is recalling approximately 7 million of the pods associated with its Omnipod, Omnipod DASH and Omnipod 5 insulin management systems due to a risk of insulin being underdelivered.
The risk stems from a manufacturing issue identified as part of Insulet’s regular quality control process. The company found that pods from certain lots may have a small tear in their tubing that could impact their ability to administer insulin as expected.
“If insulin is not delivered properly, users may experience high blood glucose levels due to underdelivery of insulin,” according to an Insulet statement. “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 and can be life-threatening if not treated.”
Around the world, a total of 24 serious adverse events associated with high blood glucose levels—including hospitalization and DKA—have been linked to this issue.
Only pods from lots specifically impacted by this safety issue are included in the recall. No continuous glucose monitoring systems are impacted in any way. Healthcare providers and patients alike can go to Insulet’s website to see if any pods in their possession have been recalled.
Incident similar, but different, from an earlier recall
Insulet emphasized that this is separate from a previous issue with certain lots of the company’s Omnipod 5 pods. That recall, first announced back in March, was linked to a total of 18 serious adverse events.
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.