The Insulet Corporation of Billerica, MA has issued a voluntary recall of certain lots of its Omni-Pod-brand insulin management system.
According to a press release issued by the U.S. Food and Drug Administration (FDA), the recalled pods may have a higher rate of failure under actual use conditions than those specified in the company’s current manufacturing standards. Specifically, the cannula may either fail to fully deploy or completely retract, resulting in patients not receiving the expected dose of insulin. Alternatively, the pod may trigger a false alarm indicating the need for replacement.
The company says that the pods affected by the recall have so far resulted in 90 Medical Device Reports, 13 of which required medical intervention. However, there have been no reports of deaths or serious injuries related to the recalled pods.
The recalled pods were distributed to consumers from December 2013 through March 2015. They are designed for use with Insulet’s OmniPod Personal Diabetes Manager, which is not affected by this recall.
Read additional information on this recall is available in the FDA’s press release.
