FDA issued recall of Miller balloon atrioseptostomy catheter and Fogarty dilation atrioseptostomy catheter by Edwards Lifesciences due to balloon deflation, fragmentation and detachment Issue.
More on the FDA website:
www.fda.gov/medical-devices/medical-device-recalls/
edwards-lifesciences-recalls-miller-and-fogarty-atrioseptostomy-dilation-catheters-due-balloon