FDA Announces recall on OmniPod Insulin Management System Units
The FDA announced on August 27 that the Insulet Corporation initiated a voluntary recall of some of its OmniPod Insulin Management System units. This is due to the possibility that certain lots of the OmniPod may have a higher rate of failure. This can happen when a cannula completely retracts or fails to fully deploy, which can result in the user not receiving the expected insulin dose. Alternatively, the OmniPod may trigger an alarm indicating that it will no longer deliver insulin and will need to be replaced. Either failure can result in hyperglycemia which can lead to diabetic ketoacidosis and an immediate need for medical treatment. If you or a loved one has been injured by an OmniPod insulin management system, contact our medical device attorneys here at The Brandi Law Firm to discuss your potential case and any legal remedies you may have.
OmniPod is an all in one tubeless insulin pump designed by Insulet Corporation. It consists of a completely tubeless”pod” that is wirelessly controlled by a Personal Diabetes Manager.
The following OmniPod lots have been voluntarily recalled:
|Distribution||Catalog Number||Description||Lot Number|
|United States||POD-ZXP420||OmniPod® Insulin Management System||L40806
|International||14810||OmniPod® Insulin Management System||L40771
OmniPods from the affected lots were distributed to customers from December 2013 to March 2015.
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