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# Cardiosave Balloon Pump Recall Class 1: FDA
- URL: https://www.fdaweb.com/cardiosave-balloon-pump-recall-class-1-fda/
- Published: 2023-08-17T12:00:00.000Z
- Updated: 2026-09-14T18:51:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155121

FDA says the Datascope/Maquet/Getinge 6/5 recall of Cardiosave Hybrid and Rescue intra-aortic balloon pumps for printed circuit board assembly failures is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/datascopemaquetgetinge-recalls-cardiosave-hybrid-and-rescue-intra-aortic-balloon-pumps-iabps-pcba?ref=fdaweb.com) says the company recalled 4,586 devices distributed in the U.S. between 5/6/2012 and 5/19/2023.

The notice says the units are used in healthcare facilities in patients with acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.

FDA says the pumps were recalled because they may shut down unexpectedly due to circuit board failures in the charging path. “If this occurs,” the notice says, “the device may lose the ability to charge batteries in one or both battery bays/slots due to electrical surge damage in the power management board charging path circuit. Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury, and death.”

The company reported 252 complaints, with no reports of injuries or death, FDA says.