HQ Team
August 11, 2023: Sweden’s Getinge Group is recalling its cardiosave hybrid and rescue intra-aortic balloon pumps after the FDA initiated a most serious recall, Class 1.
According to the FDA, the pumps may shut down unexpectedly due to electrical failures in the Power Management Board or Solenoid Board, a power source path.
About 4,586 product models, the Cardiosave Hybrid and Cardiosave Rescue, were distributed in the US between March 6, 2012 to May 19, 2023.
The electromechanical systems are used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counterpulsation.
Once the balloon is positioned in the aorta, the pump is set to work synchronously with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle.
Cardiosave Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. They are used in healthcare facilities.
Adverse events
“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death,” according to the FDA. Getinge reported 26 complaints.
There have been no reports of injuries, or death from the products sold by its subsidiaries Maquet and Datascope.
On June 5, 2023, Datascope/Maquet/Getinge sent all affected customers an important medical device advisory, requesting them to ensure there is an alternative pump available to continue therapy.
The company also urged the customers to provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.
Datascope, Maquet
Maquet and Datascope are part of Getinge Group, a leading global provider of innovative solutions for operating rooms, intensive-care units, hospital wards, sterilization departments, elderly care and for life science companies and institutions.
In 2000, Maquet was acquired by Getinge Group, leading to the foundation of the business area medical systems within the Group.
Datascope Corp., is the global leader in intra-aortic balloon counterpulsation and a diversified medical device company that develops, manufactures, and markets products for clinical healthcare markets in interventional cardiology, cardiovascular and vascular surgery, and critical care.
Getinge AB and Datascope Corp., on January 29, 2009, announced that they have received antitrust approval from the US Federal Trade Commission for their proposed merger, which took place in June.
