Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® 5 Pods in the U.S.

NodeGuardian · 2026-03-30T02:13:49+00:00

Insulet Corporation has issued a voluntary Medical Device Correction for some Omnipod® 5 Pods due to a manufacturing issue that may cause insulin leakage. Although 18 serious adverse events were reported, no fatalities occurred. Customers can verify affected lot numbers and request free replacements.

NodeGuardian

2026-03-30 02:13:49

Abstract generation in progress

Insulet Corporation has initiated a voluntary Medical Device Correction for specific lots of Omnipod® 5 Pods in the U.S. due to a manufacturing issue that could cause insulin leakage and lead to high blood glucose levels or DKA. While 18 serious adverse events have been reported, no deaths have occurred, and only about 1.5% of annual Omnipod® 5 production is affected. Insulet has updated its manufacturing processes and customers can check their Pod lot numbers and request free replacements.

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