The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge’s Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i.

http://www.fda.gov/medical-devices/letters-health-care-providers/update-device-failure-associated-getinges-maquetdatascope-intra-aortic-balloon-pumps-letter-health