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# Getinge/Datascope/Maquet Cardiosave Recall is Class 1
- URL: https://www.fdaweb.com/getinge-datascope-maquet-cardiosave-recall-is-class-1/
- Published: 2021-12-16T12:00:00.000Z
- Updated: 2026-09-14T17:26:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150785

FDA says the 10/27 Getinge/Datascope/Maquet recall of Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/getingedatascopemaquet-recalls-cardiosave-hybrid-and-cardiosave-rescue-intra-aortic-balloon-pump?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the company recalled 4,338 devices in the U.S. manufactured between 12/2011 and the present and distributed 3/6/2012 to 10/21/2021.

The devices were recalled due to complaints of fluid leaks, the notice says. Fluid entering the unit could cause pump shutdown or the inability to initiate therapy, FDA says. There have been one death and 71 complaints reported on the issue.

The Hybrid and Rescue pumps are cardiac assist devices used with patients undergoing cardiac and non-cardiac surgery and to treat adults who have acute coronary syndrome or complications of heart failure.

The company says it plans to correct all devices in the field to include various internal and external component upgrades that will be made available in an ingress prevention update kit and installed by a company representative. Customers also are to receive redesigned display and rescue covers for the Cardiosave transport console.