The Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue IABP is a cardiac assist device placed in the artery that is in the chest and abdomen (descending aorta). The device is an electromechanical system used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the heart's left ventricle through counter pulsation.  

• From January 1, 2023, through April 11, 2024, Getinge initiated eight voluntary recalls for the Cardiohelp system, including the HLS Set.   Of these, the FDA classified one as a Class I recall, the most serious type of recall. In the last 12 months, the FDA received 246 MDRs related to the Getinge Cardiohelp System, including the HLS Set.   Of those, 33 were reported as resulting in patient serious injury or death. However, as stated above it may be difficult to confirm a direct cause and effect between an adverse event report and a specific medical device based on the limited information provided in the reports. The FDA continues to have concerns regarding the sterility of the HLS Set.

• Sterility was also a concern in May 2023, when Getinge notified U.S. customers that it removed another of its cardiopulmonary bypass devices, the Quadrox oxygenators, from the U.S. market. The Quadrox oxygenators continue to be unavailable because of sterility issues.