FDA announces Class I recall of iCast stent

Atrium Medical Corporation has recalled the iCast Covered Stent System due to reports of separation of the balloon or catheter hub separation when removed from the patient, potentially causing serious patient harm, the Food and Drug Administration announced today. Health care providers should read and follow the Urgent Medical Device Correction letter and report any product performance issues to Atrium Medical Corporation, FDA said. A Class I recall is the most serious type of recall.