Dear Valued Customer,

Insulet is conducting a voluntary Medical Device Recall for specific lots of Omnipod 5, Omnipod DASH, and Omnipod Insulin Management System (Omnipod Eros) Pods due to a manufacturing issue we identified through our ongoing product monitoring.  

Pods not included in the affected lots, remain safe to use. All relevant regulatory authorities have been notified of this action.

What the issue is:

Insulet identified that some Pods from specific lots may have a small tear in the tubing (cannula) just above the skin, between the Pod and the point where the cannula enters the body.  If this occurs, insulin may leak outside of the Pod instead of being fully delivered into the body as intended, potentially leading to under-delivery of insulin. If you are using an affected Pod, you may notice wetness on your skin or Pod adhesive or detect the smell of insulin. However, in some cases, this may be difficult to detect and may go unnoticed.

If insulin leakage occurs, your blood glucose levels may rise and may not respond as expected to insulin delivery. If using Omnipod 5, and it is in Automated Mode, this could trigger an Automated Delivery Restriction alert, advising you to troubleshoot. However, this issue may happen without triggering any alert, meaning you could receive less insulin than needed without realizing it. Do not rely only on Pod alerts to know if something is wrong.

Note that this issue does not affect continuous glucose monitoring (CGM) systems or CGM readings. 

Potential Risks:

If insulin is not delivered properly, you may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), a serious medical condition that requires prompt medical treatment and can be life-threatening if not treated.

Globally, there have been 24 reports of serious adverse events associated with high blood glucose levels, including hospitalization and DKA. There have been no deaths reported.

What you need to do:

Please take the following steps immediately:

1. Check the lot number on your Pod tray lid, the Pod box or the Pod itself to determine if your Pods are affected.
   1. Provided in Appendix A are instructions and pictures to help you identify the lot number for your Pods
   2. Review the lot list in Appendix B to determine whether your Pod is impacted. DO NOT use Pods from the affected lots.
   3. All Pods within a single box will be from a single lot and if the lot is affected, do not use any of those Pods.
2. If your Pods are impacted:
   1. Discontinue use of any impacted Pod immediately. If the Pod you are currently using is from an affected lot, it is important that you immediately change your Pod to resume insulin delivery. When changing your Pod, confirm that the new Pod is not from an affected lot.
   2. Find the email with subject “ACTION REQUIRED: Review and Acknowledge Field Safety Corrective Action for Omnipod Pods” and click “Acknowledge & Check Lots” to acknowledge that your Pod is impacted and request a replacement.
3. If your Pods are not impacted:  
   1. Find the email with subject “ACTION REQUIRED: Review and Acknowledge Field Safety Corrective Action for Omnipod Pods” and click “Acknowledge & Check Lots” to acknowledge that your Pods are not impacted.
4. For additional support, call our dedicated Product Support phone line at 1-855-763-4636 available 24/7. 

You will receive a return kit with clear instructions on how to send back any unused affected Pods. 

Always check the expiration date before using a Pod. Do not use any Pod that is past its expiration date, as expired Pods may not function as intended.

If your Pod supply is depleted due to this issue, you should consult with your healthcare provider for alternative means of insulin delivery while waiting for Pods to be replaced. Always follow your healthcare provider's guidance on appropriate glucose monitoring.

What this means for users:

We know how important it is to stay on therapy without interruption and we understand how much you depend on your Omnipod every day to manage your diabetes with confidence.

Insulet has identified the cause of this manufacturing issue and implemented corrective actions designed to prevent recurrence. In addition, the Company has further strengthened its in-process monitoring and quality controls designed to detect cannula tears of this nature.  

Your safety and continuity of care are our highest priorities, and we are committed to helping you navigate this situation with minimal disruption. Our team is here to support you every step of the way, with clear guidance, responsive assistance, and a continued focus on your safety and well-being.

We have sufficient supply available to replace affected Pods and do not anticipate any disruption to product availability. 

Additional information:

For additional support, please visit the Frequently Asked Questions or call 1-855-763-4636, available 24/7. 

Thank you for taking the time to review this important information and for the trust you place in Omnipod.

Sincerely,

Chuck Medovich
Senior Vice President, Quality Assurance, Regulatory Affairs, and Compliance
Insulet Corporation

Appendix A - Lot Number Identification

The lot number can be located on the Pod tray lid, the 10-pack Pod box and the flat side of the Pod.

Pod lot number location on the Pod tray lid (circled below in red):

Pod lot number location on the side of the 10-pack Pod box (note all Pods in the same box will have the same Pod lot number):
  

 

Pod lot number location on the Pod itself (flat side):

Appendix B - List of Affected Lot Numbers