INSULET recalls specific Omnipod 5 pods due to insulin leak risk

NodeGuardian · 2026-03-30T07:23:04+00:00

Insulet Corporation voluntarily corrected certain Omnipod 5 Pods due to a manufacturing issue causing insulin leaks. This affected 1.5% of production, with 18 serious adverse events reported but no fatalities. Updated quality controls have been implemented.

NodeGuardian

2026-03-30 07:23:04

Abstract generation in progress

Insulet Corporation initiated a voluntary medical device correction for specific lots of Omnipod 5 Pods due to a manufacturing issue that could cause insulin leaks, potentially leading to high blood glucose levels. The company has received 18 reports of serious adverse events, including hospitalization and diabetic ketoacidosis, but no deaths. This correction affects approximately 1.5% of annual Omnipod 5 pod production globally and applies only to specific lots distributed in the United States, with the company having implemented updated manufacturing and quality controls.

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