Through post market surveillance and investigation of returned complaint devices, Insulet has been made aware of pdm battery issues, including battery swelling, fluid leaking from the battery, and in rare cases, extreme overheating, which may pose a fire hazard (thermal runaway events). The health hazard evaluation (HHE) was completed on October 10, 2022 with an analysis of possible causes and hazardous situations with the information that was known at the time. Recall start date: October 17, 2022
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