Abbott initiated a voluntary medical device correction in February for certain Readers in the FreeStyle Libre family of products including FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers.
The FreeStyle Libre family of readers use lithium-ion batteries, like the kinds used in mobile phones and many other handheld electronic devices, which have the potential for battery swelling, leakage or extreme overheating.
We have received a limited number of reports worldwide from users over several years that their Reader’s lithium-ion battery swelled, infrequently overheated or, in very rare cases, sparked or caught fire. Our investigation has determined that using a charging cable or power adapter that was not included with your Reader may increase the risk of a fire hazard. The Abbott-provided USB cable and power adapter limit the current to safely charge the battery, whereas third-party components may allow much higher power, increasing the risk of fire if liquid or other contaminants get into the USB port.
This notice is being communicated as a voluntary medical device correction to provide information about risks associated with the lithium-ion batteries contained only in the FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 Readers. No Readers are being physically recalled and customers can continue to use their Readers with the Abbott provided USB cable and power adapter. This does not affect any of the FreeStyle Libre family of sensors.