Acton medical device manufacturer Insulet Corp. issued a voluntary medical device correction on its Omnipod DASH Personal Diabetes Manager on Oct. 17.
The recall is related to battery issues with the device including battery swelling, fluid leaking from the battery, and, in rare cases, extreme overheating which may pose a fire hazard, according to a notice sent to customers.
Insulet specializes in diabetes care through insulin delivery devices. Its Omnipod line features wearable delivery devices, eliminating the need for tubes, and multiple daily injections.
The recall does not affect Omnipod DASH Pods, the Omnipod Insulin Management System, or the Omnipod 5 Automated Insulin Delivery System.
According to a Nov. 4 press release, there have been 50 complaints about the issues, with no serious injuries or deaths.
The company will ship updated devices to customers using the recalled devices.
“Safety is our top priority, and we have been urgently addressing this issue,” said Michael Spears senior vice president, regulatory affairs & compliance. “We are committed to helping our customers navigate the replacement process and address any concerns they have. We are confident that a software update will resolve this issue.”
