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 455 complaints involving the 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.