Insulet Launches Voluntary Medical Device Correction for Certain Omnipod® Pods Due to Potential Insulin Under-Delivery Risk
Insulet Corporation, a leading manufacturer of tubeless insulin delivery systems, has announced a voluntary Medical Device Correction affecting specific lots of Omnipod® 5, Omnipod DASH®, and Omnipod® Insulin Management System (Omnipod Eros) Pods. The action follows the identification of a manufacturing issue that could result in insulin under-delivery in certain devices, potentially placing users at risk of elevated blood glucose levels and serious diabetes-related complications.
The company stated that the issue was discovered through its ongoing product quality monitoring and surveillance programs. While the majority of Omnipod Pods continue to function as intended and remain safe for use, Insulet is taking proactive measures to address affected products and ensure patient safety.
Manufacturing Defect Linked to Insulin Delivery Problems
According to Insulet, the issue involves a small tear that may develop in the Pod’s tubing, also known as the cannula. The cannula is the component responsible for delivering insulin from the Pod into the body after insertion beneath the skin. In certain Pods from specific manufacturing lots, a defect may cause a tear in the tubing just above the skin surface, between the Pod itself and the point where the cannula enters the body.
When such a tear occurs, insulin may leak externally rather than being delivered completely into the user’s bloodstream. As a result, patients may receive less insulin than prescribed, a condition known as insulin under-delivery. Because insulin is essential for maintaining healthy blood glucose levels in people with diabetes, insufficient insulin delivery can lead to significant health risks if not promptly identified and addressed.
The company emphasized that this defect is limited to certain production lots and does not affect all Omnipod products currently in circulation.
Potential Health Risks for Users
Insulin under-delivery can have serious consequences for individuals who rely on continuous insulin administration to manage diabetes. If the body receives less insulin than required, blood glucose levels may rise above recommended ranges, resulting in hyperglycemia.
Common symptoms of high blood glucose levels include excessive thirst, frequent urination, fatigue, headaches, blurred vision, and difficulty concentrating. If insulin delivery remains inadequate for an extended period, hyperglycemia can become severe and potentially progress to diabetic ketoacidosis (DKA), a dangerous and potentially life-threatening condition.
DKA occurs when the body cannot use glucose effectively for energy due to insufficient insulin and begins breaking down fat instead. This process produces ketones, acidic compounds that accumulate in the bloodstream. Symptoms of DKA may include nausea, vomiting, abdominal pain, rapid breathing, confusion, dehydration, and fruity-smelling breath. Without timely medical treatment, DKA can lead to hospitalization, organ complications, and even death.
Insulet noted that users of affected Pods may sometimes notice warning signs indicating insulin leakage, such as moisture on the skin, dampness around the Pod adhesive, or the distinct smell of insulin. However, the company cautioned that the defect may not always be easily detectable, meaning some users could remain unaware that insulin is not being delivered properly.
Because of this possibility, affected individuals are being encouraged to identify whether their Pods belong to impacted lots and discontinue use immediately if necessary.
Scope of the Correction
The voluntary Medical Device Correction encompasses approximately 7 million Omnipod Pods worldwide. However, Insulet reported that nearly 60 percent of these Pods have already been used or have expired, reducing the number of active products currently in circulation.
The affected Pods account for approximately 8.5 percent of the company’s global Omnipod Pod production during 2025, indicating that the issue is limited to a specific subset of manufacturing lots rather than the broader product portfolio.
The correction includes affected Pods distributed in both the United States and several international markets. Insulet has not publicly disclosed every country involved but confirmed that relevant regulatory authorities in all affected regions have been informed of the action.
Importantly, Pods not listed among the affected lots remain safe to use and are not impacted by this manufacturing issue.
Separate From Previous March 2026 Correction
Insulet clarified that the newly announced correction is distinct from a previous voluntary Medical Device Correction initiated on March 12, 2026. That earlier action involved certain Omnipod 5 Pods distributed in the United States.
Although both corrective actions concern Omnipod products, the newly identified manufacturing defect represents a separate issue affecting different production lots and additional product lines, including Omnipod DASH and Omnipod Eros systems.
The company’s latest announcement expands corrective measures to include a broader group of Pods distributed across multiple markets.
Adverse Event Reports
While the occurrence rate appears relatively low compared with the millions of Pods distributed globally, Insulet acknowledged receiving reports of serious health complications associated with the defect.
Worldwide, the company has documented 24 reports of serious adverse events involving elevated blood glucose levels potentially linked to insulin under-delivery. Some of these incidents resulted in hospitalization and cases of diabetic ketoacidosis.
Despite these reports, Insulet emphasized that no deaths have been associated with the issue.
The company continues to monitor product performance closely and collaborate with healthcare providers, regulatory agencies, and affected customers to ensure any potential risks are addressed promptly.
Continuous Glucose Monitoring Systems Not Affected
Insulet stressed that the manufacturing defect does not affect continuous glucose monitoring (CGM) technology or CGM readings.
Patients who use integrated diabetes management systems that combine Omnipod insulin delivery with glucose monitoring devices can continue relying on their CGM data as usual. The issue is confined solely to insulin delivery within certain Pod lots and has no impact on glucose sensing accuracy or monitoring performance.
This distinction is important because CGM devices often serve as an early warning mechanism, helping users detect rising glucose levels that may indicate insulin delivery problems.
Root Cause Identified and Corrective Actions Implemented
Following a detailed investigation, Insulet reported that it has successfully identified the root cause of the manufacturing issue and implemented corrective measures designed to prevent recurrence.
Although the company has not publicly disclosed the exact technical details behind the defect, officials confirmed that manufacturing processes have been modified to address the problem. Additional quality assurance safeguards have also been introduced to strengthen detection capabilities during production.
Among the improvements implemented are enhanced in-process monitoring systems and expanded quality-control procedures specifically designed to identify cannula tears before products leave manufacturing facilities.
These preventive measures are intended to improve product reliability and reduce the likelihood of similar issues occurring in future production runs.
Customer Support and Replacement Program
To minimize disruption for patients and maintain access to essential insulin therapy, Insulet has established a replacement program for affected Pods.
The company is proactively contacting customers whose products may be impacted and providing instructions on how to verify lot numbers and request replacement devices. All replacement Pods will be provided at no cost to customers.
Insulet also stated that it currently maintains sufficient inventory levels to support replacement requests and does not anticipate shortages or interruptions in product availability as a result of the correction.
Customers are encouraged to review the lot number printed on their Pod packaging and compare it with the list of affected lots available through the company’s dedicated verification portal.
If a currently worn Pod belongs to an affected lot, users are advised to discontinue its use immediately and replace it with a Pod from an unaffected lot.
Regulatory Notification and Compliance
Insulet has formally notified the U.S. Food and Drug Administration (FDA) and other relevant health authorities worldwide regarding the voluntary Medical Device Correction.
Such notifications are standard practice when manufacturers identify product issues that could potentially affect patient safety. Regulatory agencies will continue to oversee the correction process and monitor the effectiveness of the company’s response measures.
The voluntary nature of the action reflects Insulet’s commitment to transparency, patient protection, and regulatory compliance while addressing the issue before it becomes more widespread.
What Users Should Do
Individuals using Omnipod systems should take the following steps:
- Check whether their Pod lot number appears on the list of affected lots.
- Stop using any Pod identified as part of the correction.
- Replace affected Pods with unaffected devices immediately.
- Monitor blood glucose levels carefully and watch for signs of insulin under-delivery.
- Seek medical attention if symptoms of severe hyperglycemia or diabetic ketoacidosis occur.
- Contact Insulet customer support for assistance and replacement products.
Users in the United States can reach Insulet Product Support through its 24-hour customer assistance line or utilize the company’s online live-chat service. International customers are advised to visit the company’s website and follow region-specific instructions provided through official notices.
About
Insulet’s voluntary Medical Device Correction underscores the critical importance of ongoing product surveillance and rapid response within the medical device industry. Although the identified manufacturing defect affects only a limited percentage of Omnipod Pod production, the potential for insulin under-delivery and serious complications such as diabetic ketoacidosis prompted immediate action from the company. By identifying the root cause, strengthening manufacturing controls, notifying regulatory agencies, and offering free replacement Pods, Insulet aims to protect patient safety while maintaining confidence in its insulin delivery systems. Customers are strongly encouraged to verify their Pod lot numbers, discontinue use of affected products, and take advantage of the company’s replacement program to ensure uninterrupted and safe diabetes management.
