Recalls for Intra-Aortic Balloon Pumps

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 Food Recall

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.

  • Company:
    Datascope Corp/MAQUET
  • Problem
    Failure To Meet Child Resistant Closure Requirement