“Without a doubt, this proposal created strong feelings across our membership," ACC President B. Hadley Wilson, MD, said in a statement. 

Abbott previously issued a voluntary medical device correction about this problem, but no recall had been announced at that time. The recall includes devices distributed from November 2017 to February 2023.

According to an advisory on the FDA’s website, there is a “reasonable probability” that any immunocompromised patients exposed to the affected antibiotic could develop a life-threatening infection.

The company emphasized that the issues are quite rare. No devices are being recalled, and it is not recommended that customers stop using them. 

This latest recall is due to a heightened risk that the devices will stop working with no warning. There have been 42 customer complaints reported so far. 

The devices have been hit with multiple recalls in recent months. Those issues are now impacting sales outside of the United States as well.

Damar Hamlin, the Buffalo Bills safety who went into sudden cardiac arrest on the football field back in January, has also highlighted the importance of this new bipartisan legislation. 

The recall, announced by the FDA, includes multiple lots of dabigatran etexilate capsules.