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  1. Cardiac

Datascope Corp/MAQUET Issues Worldwide Voluntary Recall of IABPs for Potential Electrical Test Failure

  • June 24, 2017

Submitted by: Joel DunningGold ContributorSilver Commentor

Source: US food and drug administration
Source URL: https://www.fda.gov/Safety/Recalls/ucm563583.htm

Keywords:

  • Cardiac
Author(s): FDA

Please make sure that you are aware of this recall for testing of System CS100, CS100i and CS300 Intra-aortic Balloon Pumps for electrical testing. 
Overall Action for UserPatients receiving IABP therapy are in critical condition and sudden interruption of therapy could result in unsafe, hemodynamic instability. Maquet/Getinge indicates that the risk-benefit of using an affected CS100i, CS100 or CS300 IABP should be assessed by the medical team for each patient when no alternative IABP or alternative therapy is available. Please adhere to the following instructions when using affected devices as mentioned in the link provided 
 

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  • IABP
  • Mechanical Circulatory Assistance

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