Datascope/Getinge IABPs May Malfunction Due to Cable Failure
The US Food and Drug Administration (FDA) announced yesterday that Datascope/Getinge is recalling certain CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pumps (IABP) due to a risk of device malfunction. This article provides a summary of the FDA announcement, discuss the associated risks, and outline the actions taken by the manufacturer to address the issue.
Device details
The CARDIOSAVE Hybrid and CARDIOSAVE Rescue Intra-Aortic Balloon Pumps (IABPs) are advanced electromechanical systems designed to inflate and deflate intra-aortic balloons. The devices offer temporary left ventricular support through counterpulsation. Once the balloon is appropriately positioned within the aorta, the pump operates in sync with either the electrocardiogram or arterial pressure waveform, ensuring that the balloon inflates and deflates at the correct moments during each cardiac cycle.
The devices are indicated for use in adult patients experiencing acute coronary syndrome, undergoing cardiac or non-cardiac surgery, or dealing with complications related to heart failure.
Reason for recall
The recall of CARDIOSAVE Hybrid and Rescue IABP devices has been initiated due to a potential malfunction or failure in the coiled cable that connects the unit’s display and base that may cause the system to stop functioning correctly. The malfunction can lead to a sudden interruption in circulatory support, which could result in serious injury or death. The FDA has classified this recall as a Class I recall, the most serious type, due to the potential for severe injury or death.
Affected devices and distribution
The affected devices include the CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pumps with product codes CS100i, CS300, and CS300i. These devices were manufactured between May 1, 2017, and January 31, 2021, and distributed from June 6, 2017, through February 17, 2021. A total of 1,154 affected devices were distributed in the United States.
Actions taken by Datascope/Getinge
Datascope/Getinge has taken several steps to address the issue and ensure the safety of patients. The company has sent an Urgent Medical Device Recall Notification letter to all affected customers, informing them of the potential malfunction and providing instructions on how to proceed.
Additionally, the company is offering a field correction to repair the affected devices and prevent fluid ingress. Datascope/Getinge has also set up a hotline for customers to call for assistance with the recall and field correction process.
Recommendations for healthcare professionals
Healthcare professionals using the affected CARDIOSAVE Hybrid and Rescue IABP devices are advised to follow the recommendations provided by Datascope/Getinge. These include:
- Review the Urgent Medical Device Recall Notification letter and ensuring that all staff members are aware of the issue.
- Contact Datascope/Getinge to schedule a field correction for the affected devices.
- Monitor patients closely during the use of the IABP devices to ensure proper circulatory support is maintained.
- Report any adverse events related to the use of the CARDIOSAVE Hybrid and Rescue IABP devices to the FDA’s MedWatch Adverse Event Reporting program.
Conclusion
The FDA announcement of Datascope/Getinge’s recall of certain CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pumps highlights the importance of vigilance and timely action when it comes to medical device safety.
Healthcare professionals using the affected devices should take immediate steps to mitigate the potential risks to patients. By staying informed and following the guidance provided by the FDA and Datascope/Getinge, healthcare providers can help ensure the safety and well-being of their patients.
More details
Read more details about the Datascope/Getinge recall here.
Read specific details about recalled Cardiosave Hybrid devices here.
Read specific details about recalled Cardiosave Rescue devices here.