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The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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.
Insulet is recalling the Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) after receiving reports of PDM battery issues, including:
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.
On October 17, 2022, Insulet sent users an Urgent Medical Device Correction email and letter. The letter recommended the following actions for the Omnipod DASH Insulin Management System PDM:
The company notes that users do not need to call Customer Care to receive an updated Omnipod DASH Insulin Management System PDM—these devices will be shipped to all current customers in the coming months when available. This includes users who received temporary PDMs.
Users with questions can visit the Insulet website at www.omnipod.com/insulet-alerts or call 1-800-641-2049 to speak with the Insulet Customer Care team 24 hours a day, 7 days a week.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.