Cardiosave Intra-Aortic Balloon Pump Recall Issued Over Leaks

Problems with more than 4,300 devices could lead to serious injuries or deaths, the FDA warns.

Following dozens of reported problems and at least one death, recalls have been issued for two types of Cardiosave aortic pumps which may leak fluid and cause severe or life-threatening injuries for patients.

The FDA announced this week that it was classifying a Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) recall as Class I; indicating that the agency believes continued use of the devices that may have leaking pump problems could lead to severe adverse health outcomes or patient deaths.

Datascope/Getinge/Maque first issued the recall in October 2021, indicating that the company had received complaints of fluid leaks. If fluid enters the Cardiosave device, it may cause unexpected pump shutdown or the inability to initiate cardiac therapy. The company has received at least 71 complaints about this issue with the devices, including one case that resulted in fatal injuries.

Cardiac assist devices are used with patients undergoing cardiac and non-cardiac surgery and to treat adult patients who have acute coronary syndrome or complications of heart failure.

The recall affects more than 4,300 devices sold in the United States, which have been manufactured since December 2011, and were distributed between March 6, 2012 and October 21, 2021.

Datascope/Getinge/Maquet indicated healthcare providers should examine their inventory to determine if they have any affected devices.

The company also warned that fluids should never be placed on top of the unit. In case of accidental spills, wipe the device clean immediately and have the unit serviced to ensure no hazard exists that can lead to serious harm. When the device will be used outdoors, use the Plastic Weather Display and Rescue Cover to protect it from fluid.

The company is working to correct the issue with the devices and says it will include various internal and external component upgrades which will be made available in an Ingress Prevention Upgrade kit and will be installed by a company representative.

Customers who have questions about the recall should contact Getinge/Datascope/Maquet customer service at 888-943-8872. Consumers who experienced any side effects or adverse events while using the device should report it to the FDA’s MedWatch Adverse Event Reporting Program.