This article is more than 5 years old. Information may no longer be current.

FDA: Insulet recalls lots of OmniPod insulin management system

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

In early November, Insulet Corporation initiated a voluntary recall of 15 lots of the OmniPod Insulin Management System, according to an FDA press release.

The recall is due to a slight increase in cases of the Pod’s needle mechanism failing to deploy or a delay in the deployment of the needle mechanism. There is an approximately 1% to 2% incidence in the affected lots.

Sixty-six Medical Device Reports have been issued, and three required medical intervention; however, no serious injuries or deaths have been reported.

The OmniPod Personal Diabetes Manager is not affected by the recall.

The lots were distributed in September 2015. For a list of the lot numbers recalled see the press release for more information.