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
L40811
L40895
L40976
L41014
L41025
L41067
L41162
L41171
L41197
L41198
L41250
International 14810 OmniPod® Insulin Management System L40771
L40892
L40901
L40905
L40997
L41199
L41208

OmniPods from the affected lots were distributed to customers from December 2013 to March 2015.

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Insulet is a registered trademark of Insulet Corporation  The use of this trademark is solely for product identification and informational purposes.  Insulet Corporation is not affiliated with this website, and Insulet Corporation has no affiliation with The Brandi Law Firm.  Nothing on this site has been authorized or approved by Insulet Corporation.