The Omnipod Dash is Insulet’s previous-generation insulin pump. The company since launched its FDA-cleared and CE-marked Omnipod 5 next-generation automated insulin delivery system. Insulet’s notice went out to current and past users of the Omnipod Dash insulin management system.
According to the notice in Europe on Nov. 2 and a news release posted on Nov. 4, the warning relates to the Omnipod Dash Personal Diabetes Manager (PDM) and its battery. Insulet said there have been 50 complaints — but no reports of serious injury or death — related to the Omnipod Dash PDM battery issues. The notice does not apply to the Omnipod Dash pods or the Omnipod insulin management system.
This story originally ran on Nov. 3, 2022. Updated Nov. 7 with additional details from Insulet. Executive editor Chris Newmarker contributed to this story.