FDA: Recall of St. Jude Heart Surgery Device Is Most Serious Type
The Food and Drug Administration has announced on its website that medical device maker St. Jude Medical last month recalled a device used in heart surgery because of the risk that it could cause serious injury or death.
According to the regulatory agency, in a small number of cases, the core wire of the Amplatzer TorqVue FX Delivery System, which is used to assist with the deployment of Amplatzer Occluder devices that are used to close openings between the two upper chambers of the heart, has the potential to fracture, causing injury or death.
If the devices have been successfully implanted there is no danger, but for those that have not yet been used, St. Jude sent an "Urgent Medical Device Recall Notice" to doctors to stop using it and pull whatever remaining inventory they have.
The recall was designated a Class I recall by the FDA, which is the most serious type of recall because there is a "reasonable probability that use of these products will cause serious adverse health consequences or death."
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