More than 68,000 stents recalled after multiple injuries

The Advanta V12 and iCast (bottom image) balloon expandable covered stents were recalled by Atrium/Getinge because the balloons may not deflate quickly when using thicker contrast for endovascular use.

The Advanta V12 (top) and iCast (bottom) balloon expandable covered stents were recalled by Atrium Medical, a subsidiary of Getinge, because the balloons may not deflate quickly when using thicker contrast for endovascular use. The iCast device is available in the United States, and the Advanta device is not. 

Dozens of customers have reported issues with the device’s balloon or catheter hub separating from the delivery system, mostly during off-label use in a patient's blood vessels.