During that same February 18 earnings call, McEvoy stated that "strong clinical evidence and real-world outcomes continue to earn prescriber and patient confidence" and described Omnipod 5 as the "favorite pump" for both type-1 and type-2 users in 2025. CFO Flavia Pease added that U.S. revenue growth was "above the high end of our guidance range, driven by continued demand for Omnipod 5 across type 1 and type 2 customers." At no point during the call did any executive reference a product-quality issue, a pending regulatory action, or an anticipated recall.
Only a few weeks later, the March 12 filing revealed a defect affecting Omnipod 5 Pods. The filing identified insulin leakage capable of causing diabetic ketoacidosis — a serious medical emergency. The Company's February 18 statements about Omnipod reliability, patient confidence, and demand-driven growth had not referenced any of these issues.
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