Second Recall in Less Than 2 Months for Cardiosave IABPs
In a Class I recall notice, the FDA says a coiled cable that connects the display and the base may fail, causing the IABP to shut down.
Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs) manufactured by Getinge/Datascope are being recalled due to the possibility that a coiled cable connecting the display and base may fail, leading to an unexpected shutdown and inability to restart. The US Food and Drug Administration has categorized the action as a Class I recall, the most serious type.
The devices are used in cardiac and noncardiac surgeries to provide temporary support to the left ventricle through counter pulsation.
In late January—in a recall of these same products—the FDA warned of a “blood back event,” described as a situation where damage to the balloon catheter might permit blood to flow back into the pump.
This time, the agency says there have been 44 complaints that the devices have turned off without any alarms or warning. No injuries or deaths have been reported as a result.
According to the latest recall notice, users who encounter an unexpected shutdown should attempt to restart the IABP until an alternative pump is available. If the restart fails, it is recommended that another IABP be used to continue therapy. The recall notice also advises inspecting the cable between the display and base for visible damage prior to use.
Devices that stop suddenly and remain inoperable after an attempted restart should be taken out of patient care and Datascope/Getinge representatives should be contacted. The notice states that the manufacturer has developed a hardware correction to address the shutdown issue, which is limited to IABPs distributed prior to July 24, 2017.
Other past Class I recalls of Cardiosave devices occurred in December 2021 related to fluid leaks and in October 2021 related to battery problems. Prior to that, recall actions also were tied to potential electrical test failure (June 2017), failure of the device valve (August 2017), fluid ingress (September 2017 and June 2018), possible failure at high altitudes (November 2018), and potential battery failure (July 2019).