Insulet recalled 248,288 insulin deployment devices after receiving three reports of fires and more than 400 complaints about the product's batteries swelling, leaking and overheating.
Patients who use the device and are exposed to battery fluid and extreme heat are at risk of serious injury or death from an explosion or fire, the FDA said Nov. 16.
The devicemaker recalled all serial numbers for its device, Omnipod DASH Insulin Management System Personal Diabetes Manager, which were distributed between July 2018 and August 2022. In mid-October, Insulet sent medical device correction letters about the issue, which cited an "increased risk of malfunction if [Omnipod DASH was] overcharged beyond the maximum battery voltage."