Insulet has initiated a voluntary recall for certain lots of its Omnipod 5 pods following 18 serious adverse event (AE) reports associated with a defect in the automated insulin delivery (AID) system.
The diabetes company said that the medical device correction recall relates to a small tear in the AID system’s internal tubing that deliver insulin. The issue is resulting in high blood sugar levels due to the under-delivery of insulin.
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In affected systems, insulin may leak inside the pod instead of being fully infused into the body as intended, the company explained, stressing that the issue only applied to lots that have been distributed in the US, while other Omnipod 5’s and additional products within the company’s AID range remain unaffected.
Eighteen serious AEs have been reported due to the issue, which has resulted in high blood glucose levels, including hospitalisation and diabetic ketoacidosis (DKA).
Insulet added that no deaths have been reported in relation to the issue and emphasised that it does not affect continuous glucose monitoring (CGM) systems or CGM readings of which Omnipod 5 functions alongside. Meanwhile, Insulet estimates that the pods involved in this correction represent approximately 1.5% of annual production globally.
According to GlobalData analysis, the global insulin pump market is growing at a CAGR of almost 8% and is projected to reach a valuation of $15.1bn in 2035, up from $7bn in 2025.
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By GlobalDataThe recall is a small setback for the company as it looks cement a dominant position in the expanding insulin pump market. Insulet has an opportunity to increase its market share as the patient population may look to AID systems instead of more traditional insulin pumps based on the benefits of utilising a closed-loop system for managing diabetes, as per GlobalData analysis.
Insulet achieved revenue of around $2.7bn in 2025. Speaking at the J.P. Morgan Healthcare conference in January 2026, the company claimed to have driven 66% of growth in the AID market across the last five years, with sales largely attributable to Omnipod 5.
According to a GlobalData market model, Insulet held a 25.6% share of the global insulin pump market in 2025, trailing Medtronic in pole position with a share of 30.9%.
