Cardiosave (heart pumps)

2023: Recall of about 8.8 thousand devices

At the end of January 2023, Getinge announced the recall of about 8.8 thousand cardiac devices of the Cardiosave intra-aortic balloon pump after receiving more than 100 complaints about them, including one report of the patient's death.

The recall, which began in December 2022 and was carried out by a subsidiary of Swedish medical company Datascope, concerns two models of Cardiosave's intra-aortic balloon pump. Both models of the Hybrid and Rescue device are designed to be installed in the aorta, where pumps repeatedly inflate and deflate to help control blood flow from the heart. Intra-aortic balloons are usually used in the first few days of recovery in hospital after interventional heart surgery, a heart attack, or other serious cardiac event that prevents the heart from pumping enough blood to the rest of the body.

Cardiosave (heart pumps)

Getinge FDA began the recall in December 2022 after finding that if a balloon ruptured, burst, leaks or otherwise "compromised," it could lead to blood entering the pump, according to the notice. If this happens, the pump may suddenly shut down without prior warning, preventing patients from getting proper blood flow and therefore potentially causing organ damage or death. The "reverse blood flow" event can also lead to loss of patient blood or helium entering the patient's blood from the pump. If gas bubbles form in the veins, creating embols that block blood flow, they can damage the patient's brain and other organs. In the event that a damaged pump is unknowingly used for several patients and the blood of previous patients remains in the pump, cross-infection may occur. Meanwhile, hospital staff working with pumps and even maintenance personnel tasked with fixing them may also be exposed to patients' blood if the devices are not properly contained.

Getinge received 134 complaints about the issue between October 2018 and November 2022. Among them are 12 reports of complete disconnection of devices and five adverse events involving patients, including four serious injuries and one death.

According to the FDA database as of January 30, 2023, the recall covers 8,759 balloon pumps distributed worldwide, about half of which are used in the United States. The affected devices include those that were distributed back in March 2012. The FDA assigned the recall to Class I - the most serious, meaning an increased risk of injury or death.

Getinge and Datascope are updating device operating instructions to help users minimize this risk. They are also considering developing a long-term design fix that could solve this problem.

Since the beginning of February 2023, doctors should pay close attention to several alarms in Cardiosave that may indicate a perforation of the cylinder, as well as regularly inspect the tubes of the Hybrid and Rescue devices for traces of blood entering the pump. If any damage is detected, remove the cylinder pump as soon as possible and replace it if necessary.^[1]

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