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Maquet Datascope Corp - Cardiac Assist Division recalls Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) i
Recalled May 28, 2014 · FDA recall Z-1523-2014 · Maquet Datascope Corp - Cardiac Assist Division
Hazard
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. · FDA Class I
Units
11,881 units (US 5183 and OUS 6698)
Sold at
Worldwide Distribution - USA (nationwide) and approximately 104 countries.
Description
Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning.
Product
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures.
Manufacturer(s)
Maquet Datascope Corp - Cardiac Assist Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →