Insulet Corporation — Class I: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Insulet Corporation has initiated a Class I recall for specific lots of Omnipod 5 Pods due to a manufacturing defect involving an internal soft cannula tear. This defect leads to insulin leaking within the device rather than being delivered to the user, potentially causing under-delivery or unexpected device shutoff.
This recall affects Insulet Corporation, users of the Omnipod 5 system (Model PT-001662), and healthcare professionals managing patients on this insulin pump platform. It also impacts regulatory, quality, and manufacturing departments responsible for automated delivery systems.
The Class I designation indicates that the FDA considers the defect to carry a significant risk of severe adverse health consequences or death. Operationally, this highlights a risk where the device may fail without triggering a direct leak-detection alarm; instead, alarms may only occur secondary to electrical shorts or automated delivery restrictions. For manufacturers, this suggests that internal component integrity during assembly is a critical quality attribute that requires robust validation to prevent sub-clinical failures that bypass standard sensor alerts.
Manufacturers should promptly identify if any existing inventory includes the 49 affected lots. QA teams should evaluate current manufacturing processes for automated cannula insertion or assembly to detect or prevent internal mechanical damage. Regulatory and clinical teams should ensure that if similar failure modes are identified, user instructions clearly state how to recognize under-delivery symptoms when alarms may not trigger.
Class I. Reason: Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.. Product: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. Firm: Insulet Corporation (Acton MA United States). Status: Ongoing.
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