When the devices needed for a specific procedure were not available, a group of surgeons got creative. Their one-of-a-kind approach was a success, and the patient has experienced no complications.

Customers are urged to examine their inventory, quarantine any unused products and return them to the manufacturer. 

There is a risk that these catheters will fail to retain their shape during use, causing procedure delays and creating the risk of an adverse outcome. The FDA first warned users about the issue back in August.

Three patient deaths have been linked to connectivity issues with these devices. The FDA has classified this as a Class I recall.

Hospitals located in more competitive markets may be more likely to perform TAVR instead of SAVR, according to a new analysis of more than 130,000 patients. Is this a reason for concern?

The device, currently just a prototype, could be the first of its kind to gain FDA approval.