News | Intra-Aortic Balloon Pumps (IABP) | December 16, 2021

Cardiosave Hybrid and Cardiosave Rescue IABPs Recalled Due to Reports of Fluid Leaks


December 16, 2021 — Datascope/Getinge/Maquet has recalled the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) systems because of one death and 71 complaints reported about  fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.

The company initiated this recall Oct. 27, 2021. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The CardioSave Hybrid/Rescue IIABP are cardiac 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.

The recall includes all systems made since 2011 and distributed up until Oct. 21, 2021. The FDA said the number of devices recalled in the U.S. is 4,338.

On Nov. 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.

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.

Customers who have questions about this recall should contact their Getinge/Datascope/Maquet Sales Representative, or call Customer Service at 1-888-943-8872, and press option 2, Monday through Friday, between 8 a.m. and 6 p.m. EST.

Read the FDA recall notice

Read the FDA recall of these systems in August for battery failure

 

Related IABP Recall Content:

Cardiosave Intra-Aortic Balloon Pumps Recalled Due to Battery Failure

Datascope Recalls Intra-Aortic Balloon Pumps Due to Potential Battery Failure

FDA Class 1 Recall of Maquet Datascope IABPs Due to Fluid Seepage

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump
Maquet/Datascope Intra-Aortic Balloon Pumps Might Fail on Battery Power

Find more information on IABPs

Find more cath lab technology news


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