The FDA has issued an update on Atrium Medical’s March 3 recall of its iCast Covered Stent, deeming it a Class 1 recall because of the risk of serious injury or death.

The device is a balloon-expandable stent that is delivered using a catheter to hold open the airways. The reason for the recall is potential balloon or catheter hub separation when the delivery system is being removed.

The issue seems to occur most often when the tracheobronchial stent system is used outside of the indications for use, for example to treat vascular conditions, the agency said.

There have been 75 complaints and nine injuries, but no deaths reported so far, the FDA said. The 68,812 affected products were distributed from Dec. 31, 2018, to March 31.