FDA says Insulet Omnipod Dash batteries recall is Class I

Insulet Ominipod Dash Personal Diabetes Managers — The smartphone-like Personal Diabetes Manager [PDM] is supposed to enable an Omnipod Dash user to conveniently and discreetly communicate with their Podd. [Image courtesy of Insulet]

The FDA has posted a notice that an Insulet recall related to Omnipod Dash batteries is Class I, its most serious level.

Insulet recently issued a voluntary global safety notice to warn about battery problems. 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.

The Omnipod Dash includes a Personal Diabetes Manager (PDM) — a locked-down Android mobile device with features similar to a smartphone that controls the Pod delivering insulin. The FDA says Insulet has received Insulet 455 complaints involving these battery issues, including three fires. There have been no reports of injuries or deaths.

Reported problems include battery swelling, fluid leakage from the battery, and overheating.