The US Food and Drug Administration (FDA) has given a Class I recall certification to Getinge’s Cardiosave Hybrid and Rescue Intra-aortic balloon pumps (IABP) after several issues emerged that are putting patients at risk of injury or death.
This is the third Class I recall for Getinge’s troubled IABP device this month totalling six recalls this year to date.
Getinge and its subsidiaries Maquet and Datascope have received a combined 1242 complaints in regard to the issues.
The systems are designed to give support to the left ventricle through counter pulsation. When the balloon is positioned in the aorta, the pump works in conjunction with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate during the cardiac cycle.
The problems that have triggered the recall and Class I identification include shutdowns related to incorrect docking of the IABP console into the cart, which resulted in one reported death.
Gas Gain or Gas Loss alarms stopping the device unexpectedly has caused two deaths and three injuries. Autofill Failure alarm that can cause the device to go into standby mode resulting in therapy interruption has also caused two deaths and three injuries. Overheating issues have also caused four injuries and one death.
Getinge has issued Urgent Medical Device Correction letters to every affected customer, with advice and steps of what to do to manage the various problems with the IABP device. Currently there have been 4586 devices distributed in the US that have been recalled.
In August, electrical failures meant the devices could unexpectedly shutdown, leaving patients without heart pumping-assisted therapy.
The recent Class I recall is just the latest in a long line of issues for the Cardiosave IABPs. The first, in January, involved more than 4,400 devices due to a faulty catheter. There were two more recalls in March and another one in August.