The Food and Drug Administration (FDA) on September 6 categorized the recall by Datascope/MAQUET of its CS100i, CS100, and CS300 intra-aortic balloon pumps as Class I, the most serious.
The recall was initiated because of a false blood detection alarm and ingress of fluid into the balloon pump. Device failure may result in immediate and serious adverse health consequences, including death.
The recall includes all lots manufactured from July 1, 2003, to June 16, 2017.
Posted 09/06/2017] AUDIENCE: Risk Manager, Cardiology, Surgery ISSUE: Datascope Corp./MAQUET is recalling its CS100i, CS100, and CS300 Intra-Aortic Balloon Pumps manufactured July 1, 2003 to June 16, 2017 due to False Blood Detection Alarm and Ingress of Fluid into the Intra-Aortic Balloon Pump.Read More >>