Recalls

Overview

Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks

Recall Information
FDA

Reason for Recall: Getinge/Datascope/Maquet is recalling these products due to complaints of fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.
There has been one death and 71 complaints reported about this device issue.

Who May be Affected: Health care providers using the affected Cardiosave Hybrid/Rescue IABP Patients receiving circulatory support with affected Cardiosave Hybrid/Rescue IABP

What to Do: On November 15, 2021, Getinge/Datascope/Maquet sent an Urgent Medical Device Correction Letter to customers instructing them to:

  • Immediately examine inventory to determine if they have any Cardiosave Hybrid or Rescue IABPs.
  • Follow the Instructions For Use.
  • Never place fluids on top of the unit.

In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists.

  • Use the Plastic Weather Display and Rescue Cover any time the Cardiosave Rescue IABP is used outdoors, especially when there is the possibility of wet weather.

For more information, please visit: https://www.fda.gov/medical-devices/medical-device-recalls/getingedatascopemaquet-recalls-cardiosave-hybrid-and-cardiosave-rescue-intra-aortic-balloon-pump?utm_medium=email&utm_source=govdelivery