FDA Labels Getinge’s Cardiosave Hybrid And Rescue IABP Recall A Class I Event

The Food and Drug Administration has labelled Getinge’s recall of intra-aortic balloon pumps (IABP) a class I event. The Class I recall is awarded to recalls that cause serious injuries or death. The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and the Cardiosave Rescue IABP are electromechanical systems designed to provide temporary support to the left ventricle through counter pulsation. These systems inflate and deflate intra-aortic balloons in synchrony with the electrocardiogram or arterial pressure waveform, allowing the balloon to be positioned in the aorta and inflated and deflated at the appropriate time during the cardiac cycle. Cardiosave Intra-Aortic Balloon Pumps are indicated for use in adults with acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, and are typically used in health care facilities.

According to the FDA, the recall was made due to the potential for a burst, leaking, or torn intra-aortic balloon, which could lead to a blood back event during therapy. Blood in a pump can result in several adverse consequences. For example, an unexpected pump shutdown can occur if blood comes into contact with electrical components, and this can lead to serious consequences such as hemodynamic instability, organ damage, and even death, especially for those who are critically ill. Furthermore, continuing therapy may introduce helium gas bubbles into the blood, which can cause further damage to organs. Additionally, proper containment precautions must be taken to avoid potential biohazards from cross-contaminated blood, which can expose patients to diseases such as hepatitis B, hepatitis C, and HIV.Due to device defects, 134 complaints have been filed, 12 of which include an unexpected device shutdown, 4 serious injuries, and even 1 death. Faulty devices can  not only affect people who receive circulatory support using a CardioSave Hybrid or Rescue IABP, but also on the health care personnel providing care to these individuals, as well as any users or service personnel providing service to the CardioSave Hybrid. 

On December 19, 2022, Getinge sent an Urgent Medical Device Recall letter to device users to provide guidance for managing patients if an intra-aortic balloon (IAB) is damaged. The letter advises users to not bypass IAB alarms, to pay close attention to alarm notifications, and to periodically check the IAB catheter tubing for blood. If perforation is suspected, the letter instructs users to place the patient in Trendelenburg, disconnect the catheter extender tubing, clamp extracorporeal tubing, notify the physician, and prepare for IAB catheter removal. If there is suspicion of blood entering the pump, the letter instructs users to take the pump out of service and have it evaluated by Biomed/Technical Service. The letter also notes established patient and device management strategies regarding timing to IAB catheter removal. Healthcare professionals were  advised to immediately examine their inventory for any Cardiosave Hybrid and/or Rescue IABPs, and if a blood back event is suspected, to remove the Cardiosave from patient use, report the event, and ensure that all users are aware of the notice. Additionally, they are required to distribute the clinical guidance to users in accordance with institution policy, complete and sign the included form, and return it either by e-mail or fax. Distributors should forward the letter to any customers who received affected products, and customers with questions should contact their Datascope/Getinge representative or call the technical support line.