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 (IAB). 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 IABPs because an Autofill Failure alarm may put the device in standby mode resulting in therapy interruption. When IABP therapy begins, the IABP automatically fills the balloon catheter circuit with helium. Every two hours, or during changes to atmospheric pressure, the IABP autofill process occurs. If any step of the autofill process fails or does not complete, the device will generate an “Autofill failure” alarm message and the IABP pump will stop providing therapy. If the alarm persists, the patient may experience a prolonged interruption of therapy, which will require the healthcare provider to obtain a different console to continue therapy. If another IABP console is not available for use, alternative means of providing hemodynamic support (vasopressors, inotropes or alternate therapies) may be initiated by a healthcare provider as a temporizing measure.

Interruption 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 298 complaints related to this device issue, including two deaths and up to three injuries.

On July 31, 2023, Datascope/Maquet/Getinge sent all affected customers an Urgent Medical Device Correction letter (described as “Issue 1: Autofill Alarms”).

The letter requested customers to follow these instructions for the Autofill Failure – No Helium and Autofill Failure priority alarms:

Once these steps are completed, initiate an autofill by pressing the START key, or by pressing the IAB FILL key for 2 seconds.

Getinge/Maquet/Datascope noted that the Autofill Failure – Blood Suspected alarm is caused by a leak/failure in the intra-aortic balloon (IAB) and is outside the scope of this recall.

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