Earlier this week, Abbott initiated a voluntary medical device correction to emphasize instructions for FreeStyle Libre continuous glucose monitor (CGM) readers. The company said it received a limited number of global reports (0.0017%) from users over several years saying their reader’s lithium-ion battery swelled or infrequently overheated. In very rare cases, users reported that the battery sparked or caught fire.
No readers are being physically recalled. Customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter. Customers do not need to return their readers.
Today’s FDA notice offers more detail into which devices the warning affects and how far-reaching it is. It spans the FreeStyle Libre Flash, FreeStyle Libre 14-day and the FreeStyle Libre 2 Flash. All affected products are glucose monitoring systems. The notice does not affect any of the FreeStyle Libre family of sensors.
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