Getinge/Maquet/Datascope Recalls 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.

The devices described in this recall are the same devices announced in the UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care Providers on August 31, 2023.  Please be aware, this recall is a voluntary correction, not a product removal. 

The Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices 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 IABPs 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.

Getinge/Maquet/Datascope is recalling their Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) because they may overheat when the device’s internal temperature exceeds 176 degrees Fahrenheit. When this happens, the device will generate a “System Over Temperature” alarm that puts the device in standby mode. The pump then stops providing therapy.

Interruptions in device therapy due to an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death.

Between January 1, 2021 and June 2, 2023, Getinge/Maquet/Datascope has reported 213 complaints, including four injuries and one death.

On July 31, 2023, Datascope/Maquet/Getinge sent all affected customers an Urgent Medical Device Correction letter (described as "Issue 3: System Over-Temperature”).

If a System Over Temperature alarm is generated, the letter requested customers to:

If the alarm message persists, switch to another IABP if available and contact your service representative. If no back-up IABP is available, heath care professionals must seek an alternative way of providing hemodynamic support. This can include temporary use of vasopressors, inotropes, or other alternative therapies.

To help prevent such alarms from occurring, ensure that there are no restrictions to the airflow around the Cardiosave device. Restrictions to the vents on the device can significantly increase the internal temperature of the device, leading to such temperature excursions.

Customers with questions about this recall should contact their Getinge/Maquet/Datascope representative or call Getinge/Maquet/Datascope 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).

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.

08/31/2023