Getinge subsidiary Datascope, a manufacturer of life-supporting medical devices, is recalling Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABPs) and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The potential shutdown will occur without warnings or alarms to alert the user. Once the error occurs, the coiled cord needs to be replaced for the device to work again. The issue may occur in units distributed before July 24, 2017, and affects approximately 2,300 devices.
An unexpected pump shutdown and any interruption to therapy that occurs can lead to unstable blood flow (hemodynamic instability), organ damage and/or death, especially for people who are critically ill and most likely to receive therapy using these devices, according to the FDA.
IABP Device Use
Both IABPs are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. 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 indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults.
From June 2019 to August 2022, Datascope/Getinge has reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue.