Cardiosave System - Hybrid & Rescue Intra-Aortic Balloon Pump

Manufacturer notifying its customers regarding the following four identified system conditions:

Issue 1 - autofill alarms: manufacturer received multiple complaints where Cardiosave IABP users were identifying autofill failure conditions on the devices. For those autofill failures that result from an equipment failure that the user cannot address directly, a prolonged interruption may be experienced until an alternative console can be identified. Further, if one is not available, or the patient is in transport, therapy cannot be continued. If alternative supportive measures are unavailable or ineffective until therapy can be resumed, therapy interruption can lead to death.

Issue 2 - gas loss & gas gain alarms: manufacturer received multiple complaints  where Cardiosave IABP users were reporting instances of "gas loss in IAB circuit" and "gas gain in IAB circuit" alarms while providing therapy. A delay in therapy or an interruption in therapy may be experienced while troubleshooting the patient alarm.  Should the gas loss/gas gain failure result in prolonged interruption to therapy due to the inability to successfully troubleshoot the alarm (e.g., a component failure), the hospital will need to obtain a different console. If another IABP console is not available for use, alternative means of providing hemodynamic support (vasopressors, inotropes or alternate therapies) may be initiated by a healthcare provider as a temporizing measure. If alternative supportive measures are unavailable or ineffective until therapy can be resumed, therapy interruption can lead to death.

Issue 3 - system over-temperature: manufacturer received multiple complaints wherein users reported "system over temperature" alarms associated with a loss of pumping and/or the Cardiosave system entering standby mode. Should the IABP internal temperature exceed a threshold of 80° c, the Cardiosave interrupts therapy by placing the pump in standby and notifies the user of the event. Although the user is

notified of the event by both audible and visual notification, the resulting standby mode is sudden and requires immediate user intervention to either provide alternative or supportive therapy to the patient. If alternative supportive measures are unavailable or ineffective until therapy can be resumed, therapy interruption can lead to death.

Issue 4 - fiber optic damage: manufacturer received multiple complaints where Cardiosave IABP users were experiencing a failure in the IAB fiber optic sensor input on the IABP when inserting the intra-aortic balloon fiber optic connector. Should the event occur where fiber optic signal is not available and there is no ECG signal available, therapy may be interrupted. If alternative supportive measures are unavailable or ineffective until therapy can be resumed, therapy interruption can lead to death.

This urgent medical device notification is being issued by the manufacturer to inform users of the issues observed and actions to be taken should users experience these issues. 

Recall start date: August 4, 2023