FDA Gives Update on Insulet Omnipod DASH Device Recall

In an update on Insulet’s Oct. 17 recall of its Omnipod DASH Insulin Management System personal diabetes manager device, the FDA deemed it a Class 1 recall because of the risk of serious injury or death.

The company has received reports of battery swelling, fluid leakage from the battery and extreme overheating.

The 248,288 affected devices were distributed between July 27, 2018, and Aug. 31. The company has reported 455 complaints, including three fires, but no reports of injuries or deaths related to these battery issues, the agency said.

The insulin management system is intended to deliver insulin at set and variable rates. The system consists of two parts — the wearable pump which delivers the insulin and a remote controller.

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, the FDA said.