FDA: Class I recall of Atrium Medical’s iCast Covered Stent

Editor's Note

The Food and Drug Administration (FDA) on June 2 identified the recall by Atrium Medical Corporation of its iCast Covered Stent System as Class I, the most serious.

The recall was initiated because of increased complaints about the separation of the balloon or catheter hub from the delivery system, when the delivery system is being removed from a patient.

The Stent System is a balloon expandable stent that can be delivered using a catheter to hold open and support the walls of structures within the body. It is currently indicated for use as a stent to hold open the airways. The issue occurs most often when the Stent System is used outside its indications for use,  for example, to treat vascular conditions.

To date there have been 75 complaints, 9 injuries, and no deaths. Distribution dates were December 31, 2018, to March 31, 2022.