Drugs Medical Pharma

US health regulator says heart devices recall “most serious”

A recall of Swedish makers' of heart devices has been classified by the FDA as "most serious" since they could lead to severe injuries or death.

HQ Team

January 26, 2023: Getinge, a Swiss medical technology company’s recall of heart devices has been classified by the FDA as “most serious” since they could lead to severe injuries or death.

Getinge’s unit, Datascope, has distributed its Cardiosave Hybrid Intra-Aortic Balloon Pump and Cardiosave Rescue Intra-Aortic Balloon Pump since March 6, 2012. The company has recalled 4,454 devices from the US market since December 19.

The recall followed a death and four injuries from the devices used to aid the heart in pumping more blood. 

“The FDA has identified this as a Class I recall, the most serious recall. Use of these devices may cause serious injuries or death,” according to an FDA statement.

Temporary support

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 in synchrony 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 used for the acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. They are also used in healthcare facilities.

Datascope recalls the products because a compromised intra-aortic balloon (a burst, leaking, or torn balloon) could cause blood to enter the device during therapy. 

Blood in the pump can cause the pump to shut down, leading to organ damage or death. If one continues the therapy, helium may be released into their blood.

Contaminated blood can expose patients to the potential for lifelong bacterial and viral diseases such as hepatitis B, hepatitis C, and HIV.

Datascope had reported 134 complaints about this issue, including 12 device shutdowns and five adverse events.

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