This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate Class I recall earlier this month. The company also initiated recall that the FDA determined was Class I in December 2021.
In 2021, the company recalled the systems because fluid entry could cause unexpected pump shutdown or the inability to initiate therapy. The recall earlier this month centered around the potential failure of the coiled cable connecting the display and base.
FDA’s notice today said the latest recall comes as a result of a potential communication loss. This may occur between the executive processor printed circuit board assembly (PCBA) and the video generator PCBA. It may cause an unexpected shutdown without warnings or alarms. Once this error occurs, the PCBAs need replacements for the device to work again.
Unexpected shutdown and any interruption to therapy can lead to unstable blood flow, organ damage and/or death. This is especially true for critically ill people, who are most likely to receive therapy using these devices.
Details of the latest Getinge/Datascope recall
Getinge/Datascope reported 42 complaints about PCBA communication failures leading to unexpected shutdowns. The companies received no reports of injuries or deaths related to the issue.
Since initiating the recall on Jan. 9, 2023, Getinge/Datascope recalled an estimated 4,502 devices in the U.S. The company distributed these devices between March 6, 2012, and Jan. 13, 2023.
The Cardiosave IABPs treat acute coronary syndrome, cardiac and non-cardiac surgery or complications of heart failures in adults. Their authorization covers use in healthcare facilities.
These devices inflate and deflate intra-aortic balloons to provide temporary support to the left ventricle through counter-pulsation. Once the balloon is positioned in the aorta, the pump works in synchrony with the electrocardiogram or arterial pressure waveform. It makes the balloon inflate and deflate at the right time during the cardiac cycle, the FDA said.
Getinge/Datascope sent customers an urgent medical device correction letter on Feb. 7. The letter instructed customers to use another IABP to continue therapy if an unexpected shutdown occurs. If the device remains inoperable after a shutdown, customers should remove it from patient care and contact a service representative.
The companies said they developed a software correction to address the issue. A service representative will contact customers to schedule the installation of the software when available.