Recalled Cardiosave Intra-Aorta Balloon Pumps May Unexpectedly Shutdown, Posing Serious Injury Risk for Heart Patients
Federal regulators have announced a recall for Cardiosave Hybrid and Rescue aortic pumps, following more than 200 reports involving electrical surges and unexpected device shutdowns, which could result in severe and life-threatening injuries.
The systems are used in healthcare facilities to temporarily help the heart pump properly for individuals with acute coronary syndrome, undergoing cardiac or non-cardiac surgery, or experiencing complications of heart failure.
Once the balloons are positioned in the aorta, the pump is supposed to work together with an electrocardiogram or arterial pressure waveform, to make the balloon inflate and deflate at the right time during the cardiac cycle. However, the recalled Cardiosave pumps may fail, shutting down unexpectedly, which may result in unstable blood pressure, inadequate blood supply or a vital organ injury.
The U.S. Food and Drug Administration (FDA) announced the Cardiosave Intra-Aorta balloon pump recall on August 17, giving the action a Class I designation, which means the agency believes continued use of the pumps can lead to serious injury or death.
Cardiosave Balloon Pump Problems
The FDA has received at least 252 reports of failures or problems with the devices. However, so far, there have been no reports of serious injuries or death.
The recall affects more than 4,500 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump devices. The recalled devices were distributed from March 6, 2012, to May 19, 2023.
The manufacturer first announced the recall to customers on June 5, 2023, but the FDA has now deemed that action as a class I recall.
According to the recall notice, users should not attempt to remove the battery when the battery level is at 80% charge or higher, or actively charging, to avoid electrical surges. If it is necessary to remove the battery, connect the pump’s catheter to an alternative pump to prevent interruption, turn off the device by holding the power button, unplug the device, then remove the battery.
Customers with questions about the recall can contact Datascope/Maquet/Getinge at 1-888-943-8872. Those who experience a problem with the devices or suffered side effects as a result of the recall problem should report the issue to the FDA’s MedWatch Adverse Event Reporting System.
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This isn’t the first time Cardiosave aortic balloon pumps have been affected by serious recalls. Another recall was issued for the Hybrid and Rescue balloon pumps earlier this year, following more than 130 complaints due to balloon failures and tears that led to one patient death and four serious injuries.
The Hybrid and Rescue pumps were also affected by two other recalls in years past. The most recent recall was issued after it was discovered that the pumps began to leak fluid that can cause side effects and deaths.
An earlier recall affected more than 20,000 Cardiosave devices and was issued due to unexpected battery power loss that led to at least five patient deaths.
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