FDA announces recall of 4.2M Abbott devices after hundreds of incidents, including multiple fires
The U.S. Food and Drug Administration (FDA) has announced that Abbott is recalling its FreeStyle Libre, Libre 14 Day and Libre 2 Flash glucose management systems due to issues with the readers overheating, sparking and even catching on fire.
Abbott previously issued a voluntary medical device correction about the problem. However, no recall had been announced at that time.
This is a Class I recall, which means the FDA believes the use of these devices “may cause serious injuries or death.” The recall includes 4.21 million devices distributed to customers from November 2017 to February 2023.
There have been 206 incidents worldwide—not just in the United States—related to this issue so far, including seven fires and one patient injury. As Abbott said in a prepared statement, this covers just 0.0017% of all readers sold all over the world.
Abbott and the FDA have emphasized that properly charging, storing and using all affected devices can limit any risks.
“The potential for overheating, spark or fire may occur when charging the reader with non-Abbott adapters or non-Abbott USB cables along with misuse of the reader and its components,” according to the FDA advisory. “Examples of misuse include exposure to liquids, damage, and introduction of foreign material into the ports. The Abbott-provided USB cable and power adapter limit the current to safely charge the battery, whereas USB cables and power adapters manufactured by a third party may allow much higher power, increasing the risk of fire.”
The FDA is recommending that customers stop using these devices and switch to an alternative treatment method if they do not have the Abbott-provided USB cable or power adapter. Damaged device readers, including any that show signs of “visible swelling,” and any devices that are unable to hold a charge should also no longer be used.
Also, although this is a Class I recall, no request has been made for customers to return impacted devices to the manufacturer.
Abbott shares a response
“No readers are being physically recalled and customers can continue to safely use their readers with the Abbott-provided USB cable and power adapter," an Abbott spokesperson told Cardiovascular Business. "Customers do not need to return their readers. The steps outlined at www.FreeStyleBattery.com provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter.”
Sensors not included in this recall
Abbott has also noted that its family of FreeStyle Libre sensors are not directly impacted by this recall. The specific issue only affects the company's FreeStyle Libre readers.
Click here to read the full FDA advisory.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.