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.
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This story originally ran on Nov. 3, 2022. Updated Nov. 7 with additional details from Insulet. Executive editor Chris Newmarker contributed to this story.
