• Insulet is conducting a voluntary Medical Device Correction for specific lots of Omnipod 5 Pods due to a manufacturing issue we identified through our ongoing product monitoring.  
• Our team identified that certain Omnipod 5 Pods from specific lots may have a small tear in the internal tubing that delivers insulin.  
• As a result, insulin may leak inside the Pod instead of being fully infused into the body as intended.  
• This could lead to the under-delivery of insulin and result in high blood glucose levels. 

• If you use an affected Omnipod 5 Pod, you may receive too little insulin and experience high blood glucose levels.  
• 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.  

• Yes, we have notified the U.S. Food and Drug Administration (FDA).
   

• First, check your pod lot number(s) by visiting here.  The lot number can be found on the Pod tray lid, on the flat bottom of the Pod itself, and also on the side of the 5-Pack Pods box.  All Pods in the same box will have the same lot number.
• If your Pods are affected, use our live agent chat to request replacement Pods by clicking the Podder Support button in the lower right of this page or call Insulet Product Support at 1-800-641-2049, available 24/7.  
• It is very important that you DO NOT use Omnipod 5 Pods from the affected lot. You will receive a return kit with clear instructions on how to send back any unused affected Pods

• If you are currently using an affected Omnipod Pod, discontinue use immediately.  
• Please note there may be multiple Pods from the same affected lot within a single box.  
• It’s very important that you do not use any Omnipod 5 Pods with the listed lot numbers.  
• Confirm if your Pod lot is affected by visiting here.
• To request a replacement Omnipod 5 Pod, please utilize our live agent chat by clicking the Podder Support button in the lower right of this page or call Insulet Product Support at 1-800-641-2049, available 24/7. 

• You can use our live agent chat by clicking the Podder Support Button in the lower right of this page or you can call the Insulet Product Support dedicated line at 1-800-641-2049, available 24/7. 

• We emailed all Omnipod 5 users from “The Omnipod Team” with a link to acknowledge receipt of the voluntary Medical Device Correction.  
• If you did not get or cannot find this email, have questions, or need further guidance, please reach out to our live agent chat clicking on the Podder Support button in the lower right of this page or call our dedicated Product Support at 1-800-641-2049, available 24/7.  

• There have been 18 reports of serious adverse events associated with high blood glucose levels, including hospitalization and diabetic ketoacidosis (DKA), due to the issue with the Omnipod 5 Pods.  There have been no deaths reported.  

• This issue is limited to specific Omnipod 5 Pods from identified lots distributed in the United States. It does not affect other Omnipod products.  Pods not included in the affected lots are safe to use. 

• No, this issue is limited to Omnipod 5 Pods distributed in the United States only.

• Yes. We do not anticipate an interruption to customer shipments or the ability to start new customers on Omnipod 5.  
• We have sufficient supply available to replace affected Pods and do not anticipate any impact to product availability.  
• Following our investigation, we have implemented updates to our manufacturing processes and quality controls to strengthen detection and prevention and further support the integrity of our products.

• The issue with the Omnipod 5 Pods was identified through routine monitoring of customer feedback. When the issue was detected, Insulet promptly identified the affected Omnipod 5 Pod lots and initiated this voluntary Medical Device Correction.  
• Following our investigation, we have implemented updates to our manufacturing processes and quality controls to strengthen detection and prevention and further support the integrity of our products. 

• The Medical Device Correction is for specific lots of Omnipod 5 Pods distributed in the Unites States. All other Omnipod 5 pods and Omnipod Products remain safe to use.

• Following thorough investigation, we have implemented updates to our manufacturing processes and quality controls to strengthen detection and prevention and further support the integrity of our products.

• We are asking all customers to review and acknowledge receipt of the email communication that came from “The Omnipod Team”.  
• If you cannot find this email, or need further guidance, please use the Podder Support button in the lower right of this page or call Insulet Product Support at 1-800-641-2049, available 24/7.  

• Please confirm that your Pod is affected and follow the instructions.
• If your Omnipod 5 Pods are affected, use our live agent chat to request replacement Pods by using the Podder Support button in the lower right of this page or call Insulet Product Support at 1-800-641-2049, available 24/7.
• DO NOT use an affected Omnipod 5 Pod.  You will receive a return kit with clear instructions on how to send back any unused affected Pods.  

• To check if your Pod lot is affected, visit here.
• The Pod lot number can be found on the Pod tray lid, the 5-pack Pod box or the Pod itself.

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

Pod lot number location on the side of the 5-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 (bottom)

• There may be multiple Pods from impacted lots within the same box. You should not use any Pods from the identified lots.  
• When changing your Pod, confirm the new Pod is not from an affected lot. The risk of under-delivery increases if you use more than one affected Pod in a row.   

• Yes, this issue is limited to specific Omnipod 5 Pods from identified lots and does not affect other Omnipod products.  Omnipod 5 Pods not included in the affected lots are safe to use.

• Alarms may occur for many different reasons, and indicate your Pod is no longer working properly. Most alarms are not due to the issue described in the Medical Device Correction.
• If fluid leaks inside the Omnipod 5 Pod, this can lead to a hazard alarm to notify users to remove their Pod.  
• For any alarm, please follow the instructions on the Omnipod 5 app or in the user guide and change your Pod immediately to resume full insulin delivery.  
• When changing your Omnipod 5 Pod, confirm the new Pod is not affected by this correction by checking the lot number as the highest risk of under-delivery may occur when multiple Pods affected by this issue are used consecutively.
• Users should not rely solely on the alarm and should check the lot number on their Omnipod 5 Pod packaging or device to determine if their Pods are from affected lots.

• Yes, we will replace the affected Omnipod 5 Pods with new unaffected Pods provided at no cost.  
• To request replacement Pods, use our live agent chat by clicking the Podder Support button in the lower right of this page or call Insulet Product Support at 1-800-641-2049, available 24/7.  
• In your replacement package, you will receive a return kit with clear instructions to send back any unused affected Pods 

• Once you submit your request, you can expect to receive delivery within 8-10 business days. You’ll receive tracking information as soon as your order is processed.  

• If you do not have Omnipod 5 Pods you can use because of this issue call Insulet Product Support at 1-800-641-2049, available 24/7, to let them know of your circumstances. They will assist you in expediting shipping of replacement Omnipod 5 Pods via overnight delivery, or the following business day if your replacement was requested outside of USPS & FedEx shipping hours.  
• Please also contact your healthcare provider. They can help you choose an alternative method of insulin delivery while you wait for your replacement Pods.  

• Yes, we ask that you return any unused affected Omnipod 5 Pods as soon as you can. It is very important that you do not use Omnipod 5 Pods from the affected lot numbers. You will receive a return kit with clear instructions for how to send back any affected Pods.  

• Yes. If your Omnipod 5 Pods are affected, you will receive a return kit with clear instructions for sending back any affected Pods at Insulet’s expense. This step will happen after by using the Podder Support button in the lower right of this page to request replacement Pods or calling Insulet Product Support at 1-800-641-2049, available 24/7.  

• No. Replacement Omnipod 5 Pods provided as part of this voluntary Medical Device Correction (MDC) will be issued directly by Insulet and will not require a new prescription or copay.

• Replacement Omnipod 5 Pods provided as part of this voluntary Medical Device Correction will be issued directly by Insulet rather than the pharmacy and therefore should not affect insurance authorization limits. To request replacement Omnipod 5 Pods use our live agent chat by clicking the Podder Support button in the lower right of this page or call Insulet Product Support at 1-800-641-2049, available 24/7.