Insulet Recalls 1.5% of Omnipod 5 Pods After 18 Serious AE Reports
Insulet has voluntarily recalled Omnipod 5 pods from US distribution after 18 serious adverse event reports of insulin under-delivery due to a small tear in internal tubing. The defect, affecting roughly 1.5% of annual global production, has led to high blood glucose levels, hospitalizations and diabetic ketoacidosis.
1. Recall Details
Insulet initiated a voluntary medical device correction for specific lots of Omnipod 5 pods distributed in the US after identifying a small tear in the internal insulin-delivery tubing. Only pods from affected lots—approximately 1.5% of the company’s annual global production—are subject to the recall, while other Omnipod 5 devices and AID products remain unaffected.
2. Reported Adverse Events
The company received 18 serious adverse event reports linked to under-delivery of insulin, resulting in high blood glucose levels, hospitalizations and cases of diabetic ketoacidosis. Insulet confirmed no deaths have been reported in connection with the tubing defect or recall.
3. Market Context and Outlook
The global insulin pump market is growing at an almost 8% CAGR, projected to reach $15.1 billion by 2035 from $7 billion in 2025. Insulet generated roughly $2.7 billion in revenue in 2025 and held a 25.6% share of the insulin pump market, having driven 66% of AID market growth over the past five years with Omnipod 5.