Insulet Initiates Voluntary Medical Device Correction for Certain Omnipod® Pods in the U.S. and Affected International Markets
Insulet Corporation initiated a voluntary Medical Device Correction for specific lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue.
The alert affects Insulet Corporation, healthcare providers prescribing Omnipod systems, and patients utilizing the specific affected lots of insulin management pods.
The notification indicates a manufacturing-level failure that spans multiple product generations (Omnipod 5, DASH, and Eros), suggesting a potential systemic quality control issue. This likely triggers significant post-market surveillance obligations and internal CAPA (Corrective and Preventive Action) investigations to identify the root cause of the defect.
Regulatory and QA teams should verify if any internal inventory or clinical trial sites are utilizing the affected lots. Affected lots should be quarantined immediately, and companies should prepare for field safety notices as part of the formal correction process.
ACTON, Mass.--(BUSINESS WIRE)-- Insulet Corporation, Inc. (NASDAQ: PODD) (“Insulet” or the “Company”) today announced a voluntary Medical Device Correction for specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue, identif
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