Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature Alarms Causing Pump Stops

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.  

Recalled Product

• Recalled Product:
  • Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
• Product Models:
  • Cardiosave Hybrid
  • Cardiosave Rescue
• Distribution Dates: March 6, 2012 to May 19, 2023
• Devices Distributed in the U.S.: 4586
• Date Initiated by Firm: July 31, 2023

Device Use

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.    

Reason for Recall

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.

Who May be Affected 

• People who receive circulatory support using a Cardiosave Hybrid or Rescue IABP
• Health care personnel providing care that includes the Cardiosave Hybrid or Rescue IABP

What to Do 

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: 

• Turn the device OFF by pressing and holding the green IABP Power Button, located on the back panel, for two seconds
• Wait 10 seconds
• Turn the device ON by pressing and releasing the green IABP Power Button

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.

Contact Information 

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).

Additional Resources

• Medical Device Recalls database 
• Letter to Health Care Provider
• Getinge/Maquet/Datascope - Urgent Medical Device Correction

How do I report a problem?

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.