The FDA recently warned healthcare professionals of a recall of Freedom Driver System by SynCardia Systems. The Freedom Driver System operates and monitors SynCardia’s Total Artificial Heart, which serves as a temporary “mechanical replacement for a patient’s heart.” SynCardia Systems has recalled certain lots of these defective medical devices that were distributed between November 2014 and July 2015. The reason for the nationwide recall is a faulty drive mechanism that “may fail and cause the device to stop pumping.” This, in turn, would lead to almost immediate loss of consciousness, making a serious injury or death likely “if [the patient is] not immediately switched to a backup driver…”
SynCardia Systems has sent an Urgent Medical Device Recall letter with safety instructions to its customers. The initiated recall is Class I – the most serious type of recall used when “there is a reasonable probability that use of [the defective devices] will cause serious adverse health consequences or death.”
One of FDA’s primary responsibilities is protecting the public health by ensuring that pharmaceuticals and medical devices in use are safe. As such, the FDA oversees the recall process, or market withdrawal, of dangerous pharmaceuticals and defective medical devices.