Insulet recalls OmniPods on needle deployment issue

The FDA said today that Insulet (NSDQ:PODD) last month recalled 18 lots of its flagship OmniPod insulin management system due to a needle deployment issue.

No serious injuries or deaths were reported as a result of the problem, revealed by a slight increase in reports of failed or delayed needle deployment. The reported incidence is 1% to 2%, the federal safety watchdog said. Insulet notified customers Nov. 2, the FDA said.

Fifteen of the lots were distributed in the U.S. and another 3 sent overseas, according to the FDA, which noted that Billerica, Mass.-based Insulet corrected its manufacturing process and added inspectional steps once it learned of the issue. The problem, which resulted in 66 medical device reports, does not affect the personal diabetes manager used with the OmniPod device.

A list of the affected lots can be found here. Insulet did not immediately respond to a request for comment.

In July, the company pulled more than 408,000 OmniPods after receiving reports of problems affecting their ability to deliver insulin.

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