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Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods
The FDA has updated the communication “Insulin Pump Recall: Insulet Removes Certain Omnipod 5 Pods” to inform the public of new affected lots of Omnipod 5 Pods and provide additional information about this recall. The update also confirms that this issue, previously communicated as “Early Alert: Insulin Pump Issue from Insulet”, has been confirmed as a Class I Recall.
Insulet stated that Pods from certain lots may have a small tear in the internal tubing that delivers insulin. If this happens, insulin may leak inside the Pod instead of being fully infused in the body as intended, potentially leading to under-delivery of insulin. If there is a fluid leak inside the Pod, users may receive a hazard alarm notifying them to remove the Pod. In some cases, there may be no alarm or alert, and the issue may go unnoticed, potentially leading to under-delivery of insulin with the potential for prolonged high blood glucose levels.
This 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.
Questions?
Customers in the U.S. with questions about this recall should contact Insulet at 1-800-641-2049 or visit https://www.omnipod.com/current-podders to reach a live agent chat.
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