Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps For Potential Mechanical Failure of the Power Supply Fan Assembly

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Mon, 12 May 2014 10:59:48 -0500

Title:     Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps  For Potential Mechanical Failure of the Power Supply Fan Assembly

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Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of the System 98/98XT, CS100, CS100i and CS300 Intra-Aortic Balloon Pumps For Potential Mechanical Failure of the Power Supply Fan Assembly

05/12/2014 10:04 AM EDT

In March 2014, Datascope Corp/MAQUET initiated a voluntary worldwide field correction of certain Intra-Aortic Balloon Pumps (IABPs) sold under the Datascope Corp. System 98/98XT (Part Numbers: 0998-00-0446-xx, 0998-UC-0446-xx, 0998-00-0479-xx, 0998-UC-0479-xx), CS100/CS100i (Part Numbers: 0998-00-3013-xx, 0998-UC-3013-xx, 0998-UC-0446Hxx and 0998-UC-0479Hxx) and CS300 (Part Numbers: 0998-00-3023-xx, 0998-UC-3023-xx) IABP brand names for a potential mechanical failure of the fan assembly associated with the power supply.

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