FDA Class I Recall: Cardiosave Hybrid and Cardiosave Rescue IABP by Getinge/Datascope/Maquet
The U.S. Food and Drug Administration (FDA) has announced that Getinge/Datascope/Maquet is recalling the Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) due to complaints of fluid leaks. Fluid entering the Cardiosave Intra-Aortic Balloon Pump (IABP) may cause unexpected pump shutdown or the inability to initiate therapy.
The FDA has classified this as a Class I Recall. There has been one death and 71 complaints reported about this device issue.
The CardioSave Hybrid/Rescue IABPs are cardiac (heart) assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.
Getinge/Datascope/Maquet plans to correct all IABP devices in the field to include various internal and external component upgrades that will be made available in an Ingress Prevention Upgrade Kit and will be installed by a Getinge/Datascope service representative.
RECOMMENDATIONS: 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.
- 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.
Getinge/Datascope/Maquet plans to correct all IABP devices in the field to include various internal and external component upgrades that will be made available in an Ingress Prevention Upgrade Kit and will be installed by a Getinge/Datascope service representative. Customers will also receive redesigned Display and Rescue Covers for the Cardiosave transport console.
