Datascope/Getinge Recalls Certain Cardiosave Hybrid and Rescue Intra

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

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The Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and the Cardiosave Rescue IABP are electromechanical systems used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the left ventricle through counter pulsation. Once the balloon is positioned in the aorta, the pump is set to work in synchrony with the electrocardiogram or arterial pressure waveform to make the balloon inflate and deflate at the right time during the cardiac cycle.

Cardiosave Intra-Aortic Balloon Pumps are indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure in adults. They are used in health care facilities.

Datascope, a subsidiary of Getinge, is recalling Cardiosave Hybrid IABPs and Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user. Once the error occurs, the coiled cord needs to be replaced for the device to work again. The issue may occur in units distributed before July 24, 2017.

An unexpected pump shutdown and any interruption to therapy that occurs can lead to unstable blood flow (hemodynamic instability), organ damage and/or death, especially for people who are critically ill and most likely to receive therapy using these devices.

From June 2019 to August 2022, Datascope/Getinge has reported 44 complaints about damaged coiled cords resulting in unexpected shutdowns. There have been no reports of injuries or deaths related to this issue.

On February 7, 2023, Datascope/Getinge sent customers an Urgent Medical Device Correction letter. The letter offered the following clinical guidelines and user actions related to the coiled cord connection issue as part of a list of several notifications.

The letter states that this issue is limited to units distributed prior to July 24, 2017. Datascope/Getinge has developed a hardware correction to address this issue, and a service representative will contact customers to schedule installation of the correction when the correction kit is available.

Customers with questions about this recall should contact their Datascope/Getinge representative or call Datascope/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

03/17/2023