Insulet Recalls Omnipod Pods After Insulin-Delivery Failure Risk Identified, FDA Says

 his recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products and recommendations for what to do with the devices below have not changed. 

Affected Product

The FDA is aware that Insulet has issued a letter to affected customers recommending certain Omnipod Pods be removed from where they are used or sold. Affected devices:

• Omnipod 5 Automated Insulin Delivery System 
• Omnipod DASH Insulin Management System 
• Omnipod Insulin Management System (Omnipod Eros) 
• Full List of Affected Product

What to Do

Do not use Pods from affected lots. Check all Pods to determine if they are affected. If you are currently using a Pod from an affected lot, immediately change your Pod to resume insulin delivery. If you do not have enough Pods due to this issue, talk to your healthcare provider about other methods of insulin delivery.

On May 26, Insulet sent all affected customers a letter recommending the following actions:

• DO NOT use Pods from the affected lots. 
  • Check the lot number on your Pod tray lid, the Pod box or the Pod itself to determine if your Pods are affected. 
  • Follow Insulet’s instructions and pictures to help identify the lot number for your Pods 
  • Review the lot list to determine whether your Pod is impacted.  
  • 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. 
• If your Pods are impacted: 
  • 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.  
  • Follow the instructions provided by Insulet in their customer email to acknowledge that your Pod is impacted and request a replacement.  
  • For additional information, call Insulet’s Product Support phone line at 1-800-641-2049, available 24/7. 
• Users 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, 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. 

Reason for Recall

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.

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.

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

As of May 20, Insulet has reported 24 serious injuries and no deaths associated with this issue.

https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-recall-insulet-removes-omnipod-pods