Omnipod Recalled Due to Possibility of High Failure Rate

  • Aug 2015

Insulet Corporation has announced a voluntary recall of 40,846 boxes of the OmniPod (Pod) Insulin Management System due to the possibility that some Pods may have a higher rate of failure than current manufacturing standards.

This recall is a result of the cannula failing to fully deploy or completely retract which may result in the patient not receiving the intended dose. The Pod may also trigger an alarm indicating that it will no longer deliver insulin and need to be replaced.

The affected Pods were distributed from December 2013 to March 2015. The U.S. Food and Drug Administration has posted a list of the Pod lots that have been recalled. The lot number can be found on the Pod tray lid label or on the side of each individual Pod. Please note that this recall does not affect the OmniPod Personal Diabetes Manager.

For a list of recalled products, click here.

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