Recall by Datascope/Getinge of 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 a communication loss between the executive processor printed circuit board assembly (PCBA) and the video generator PCBA may cause an unexpected shutdown. This shutdown will occur without warnings or alarms to alert the user. Once the error occurs, one or both of the PCBAs will need to be replaced for the device to work again.

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.

Datascope/Getinge reported 42 complaints about PCBA communication failures resulting in unexpected shutdowns. There are no reports of any 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 PCBA communication failure as part of a list of several notifications.

Datascope/Getinge has developed a software correction to address this issue, and a service representative will contact customers to schedule installation of the software when it 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.

03/31/2023