Dexcom issues new recall for CGM apps due to safety risk—users urged to update immediately
The U.S. Food and Drug Administration (FDA) has announced that Dexcom is recalling multiple smartphone apps and a smartwatch app used with its line of continuous glucose monitoring (CGM) systems. Unlike many recalls, this is not a product removal; instead, anyone using the impacted CGM devices are urged to update their apps immediately.
Even though it is not a product removal, the FDA did rule that this is a Class I recall. That means the agency believes patients face a risk of serious injury or death if these apps are used without being immediately updated.
This recall covers the Android, iOS and watchOS apps associated with Dexcom’s G7 CGM as well as the Android and iOS apps associated with Dexcom’s One+ CGM.
The reason behind the recall
This recall was put in place due to a software design error that causes users to miss a “Sensor Failed” alert when the device’s transmitter experiences hardware/firmware failure.
“The failure to alert the user of a failed transmitter may result in the user being unaware of extended periods of missed glucose data, notifications, alerts and alarms, which may result in a delay in treatment of prolonged episodes of severe hypoglycemia or hyperglycemia,” according to the FDA’s advisory. “The use of affected product may cause serious adverse health consequences, including hypo/hyperglycemia and death.”
No injuries or deaths have been linked to this software issue.
More than 700,000 Dexcom CGMs were previously recalled due to safety issues
Back in June, Dexcom issued four separate recalls for its CGM systems due to audio issues that could lead to missed alerts. This included 602,000 Dexcom G7 CGMs, more than 38,000 Dexcom One CGMs, more than 36,000 Dexcom G6 CGMs and more than 26,000 Dexcom One+ CGMs.
The audio issues were linked to 56 adverse events. Dexcom replaced the CGMs at no charge for all customers.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.