The FDA Calls Them ‘Recalls,’ Yet the Targeted Medical Devices Often Remain in Use

Despite ordering the most serious Class-I recall in 2016 for its MitraClip heart device, Abbott failed to stop the device from being used in operations, due to a loophole that allows recalls to institute “corrections” instead of “removals”. The FDA permitted the use of the device, after Abbott revised implantation instructions and mandated training for surgeons, despite stating that the device “may cause serious injuries or death”.