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Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION
Recalled February 18, 2015 · FDA recall Z-1062-2015 · Maquet Datascope Corp - Cardiac Assist Division
Hazard
Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle. · FDA Class II
Units
838 units-US; 364 units - OUS
Sold at
Worldwide Distribution
Description
Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.
Product
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.
Manufacturer(s)
Maquet Datascope Corp - Cardiac Assist Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →