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A recall has been issued for the Maquet Datascope Corporation, Intra-Aortic Balloon Pumps, System 98/98XT, CS100/CS100i, and CS300 for the potential failure of fan assembly that may cause pumps to shut down without any alarm. The firm received 106 reports of device malfunctions. There were zero injuries and one death. The firm determined that the fan assembly for the affected IABPs could contain a misshapen retaining ring. This retaining ring could separate within the fan assembly, causing the fan to stop rotating. This could result in the power supply overheating and the IABP would shut down without any warning. This device failure would cause the balloon to stop inflating and deflating. It may result in decreased blood flow to the heart and the rest of the body, difficulty in weaning the patient from cardiopulmonary bypass, and clotting or blockage of blood vessels to the intestines, kidneys, or legs. The possible long range consequences of this include organ injury or tissue damage, possibly leading to patient death. For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm398432.htm
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