Insulet voluntarily corrects Omnipod 5 pods; 18 serious adverse events, up to $40M cost

INSULET CORP

Voluntary medical device correction for specific lots of Omnipod 5 Pods due to small tear in internal tubing causing under-delivery of insulin.
Insulet received 18 reports of serious adverse events including hospitalization and DKA; no deaths reported.
Affected pods represent approximately 1.5% of annual Omnipod 5 production; other products unaffected.
Insulet expects up to $40 million in correction costs in 2026, excluded from adjusted results; 2026 guidance unchanged.
Insulet implemented manufacturing process updates and notified FDA; customers can check lot numbers and get free replacements.

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