Insulet Recalls Omnipod 5 Pumps Over Insulin Delivery Issue

Insulet has recalled certain lots of its Omnipod 5 due to a defect that may cause under-delivery of insulin. A small tear in the device’s internal tubing can lead to insulin leaking inside the pod instead of being properly delivered.

The issue has been linked to 18 serious adverse events, including high blood glucose, hospitalisation, and cases of Diabetic Ketoacidosis, though no deaths have been reported.

The affected units represent about 1.5% of annual production. Insulet is providing free replacements and has implemented manufacturing and quality control improvements.

The company expects recall-related costs of up to $40 million but maintains its 2026 revenue growth forecast. It also does not anticipate disruptions to supply or patient access.

Analysts believe the recall is unlikely to significantly impact Insulet’s market position despite being an operational setback.

15-03-2026