Cardiosave Hybrid

2023

Balloon pump recall

On August 10, 2023 U.S. Food and Drug Administration (FDA) , it reported the recall of defective intra-aortic balloon pumps. Getinge These devices can suddenly shut down, posing risks to patients' health and lives.

We are talking about Cardiosave Hybrid and Cardiosave Rescue products manufactured by Datascope (a subsidiary of Getinge). The FDA's official notice says the spontaneous shutdown of defective pumps is due to electrical failures in the power management board or other components included in the power subsystem. The recall program applies to products supplied to the market from March 6, 2012 to May 19, 2023. A total of 4,586 defective systems have been admitted to various health facilities.

FDA reports recall of defective Getinge intra-aortic balloon pumps

Intraortic balloon pumps are used for cardiogenic shock in patients with acute left ventricular insufficiency. These systems are designed to mechanically pump blood into the aorta. Thus, the use of devices that can suddenly stop performing such an important function can cause significant harm to the patient's health (including unstable blood pressure, insufficient blood supply or damage to vital organs) or provoke a fatal outcome.

Getinge and Datascope received 26 reports of equipment malfunction, it said. Any negative consequences associated with the use of these devices were not recorded. Medical institutions that have purchased defective systems are advised to ensure that an alternative intra-aortic balloon pump or alternative hemodynamic support is available prior to therapy.^[1]

Recall of defective pumps

On March 17, 2023, the Food and Drug Administration (FDA) warned of the recall of defective Getinge intra-aortic balloon pumps, the use of which poses a threat to patient health, including the risk of death.

We are talking about Cardiosave Hybrid and Cardiosave Rescue IABP intra-aortic balloon counterpulsation devices supplied to the market by Datascope, a subsidiary of Getinge. These systems are used in cardiogenic shock in patients with acute left ventricular insufficiency. The principle of operation of the devices is to mechanically pump blood into the aorta using a special pump, which contributes to an increase in blood flow in the coronary arteries and provides temporary support for ventricular function.

Defective Getinge intra-aortic balloon pumps are being recalled

The FDA notice says the devices named may have problems with the cable connecting the monitor and base. This causes the system to suddenly shut down - without any prior warning or alarm. It is said that any unexpected pump shutdown and interruption of therapy can lead to unstable blood flow, organ damage and/or death. This is especially true for seriously ill patients receiving care through Cardiosave devices.

The defect is present in systems supplied from March 6, 2012 to July 20, 2017. In the United States alone, about 2,300 defective installations are subject to recall. Dozens of complaints have been registered related to the sudden shutdown of Cardiosave devices. It is noted that Datascope has already created a hardware fix to solve this problem, and a support representative will contact medical institutions to plan the necessary repair work.^[2]

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