FDA Alert: Insulet recalls Omnipod DASH Insulin Management System’s Personal Diabetes Manager for risk of battery swelling, leakage, or extreme overheating
Insulet is recalling the Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) after receiving reports of PDM battery issues, including:
- Battery swelling
- Fluid leakage from the battery
- Extreme overheating that may pose a fire hazard
Users could be exposed to battery fluid and extreme heat, including the potential for an explosion and/or fire, which could lead to serious injury or death.
Insulet reports 455 complaints involving these battery issues, including three fires. There have been no reports of injuries or deaths.
The Omnipod DASH Insulin Management System is used to deliver insulin at set and variable rates to manage diabetes in people who need insulin. It includes two main parts: The wearable and tubeless pump which delivers the insulin, called the Pod, and a remote controller called the Personal Diabetes Manager (PDM). The PDM is a small, reusable handheld rechargeable battery-powered locked-down Android mobile device with features similar to a smartphone. The Pod is controlled exclusively using the PDM and the two parts interact wirelessly using secure Bluetooth.
The recall affects 248,288 Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager devices in the United States that were distributed between July 27, 2018 to August 31, 2022.