This recall relates to the Swedish medtech company’s Cardiosave Hybrid and Cardiosave Rescue IABPs. Both devices were subject to a separate recall that the FDA determined was Class I in December 2021.
Getinge’s Datascope subsidiary initiated their latest recall of an estimated 2,300 devices on Jan. 9, 2023. They distributed affected devices between March 6, 2012 and July 20, 2017, according to an FDA notice.
To date, Getinge received 44 complaints related to the latest issue with no reported injury or death.
Reason for the Getinge/Datascope recall
The Cardiosave IABPs 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.
Cardiosave IABPs hold indications for treating acute coronary syndrome, cardiac and non-cardiac surgery or complications of heart failure in adults.
Datascope recalled the systems due to the potential failure of the coiled cable connecting the display and base on the Cardiosave systems. This may cause an unexpected shutdown. That shutdown can occur without warnings or alarms to alert the user.
Once the error occurs, the coiled cord requires replacement to work again. This issue may occur in units distributed before July 24, 2017.
Getinge/Datascope said that any unexpected pump shutdown and interruption to therapy can lead to unstable blood flow, organ damage and/or death. This especially rings true for critically ill users receiving therapy from these devices.
What should users do?
Getinge/Datascope sent customers an urgent medical device correction letter on Feb. 7, 2023. It offered guidelines and user actions related to the coiled cord issue.
Users should inspect their coiled cable cord for visible damage prior to use. If an unexpected shutdown occurs, users should attempt to restart the system until an alternative becomes available. If the restart attempt fails, the user must use another IABP to continue therapy.
Should the device remain inoperable after a shutdown, Getinge/Datascope told users to remove it from patient care. Then, users must contact a service representative to identify the cause and take necessary actions.