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:
- Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
- Product Models:
- Distribution Dates: March 6, 2012 to May 19, 2023
- Devices Distributed in the U.S.: 4586
- Date Initiated by Firm: July 31, 2023
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 IABPs due to unexpected shut downs related to incorrect docking of the IABP console into the cart (Hybrid Mode). If the Cardiosave IABP is not docked into the cart correctly, it will not receive AC power and will unexpectedly run on battery power (Rescue Mode) and will shut down upon battery depletion. Additionally, if the Cardiosave IABP is not docked into the cart correctly (Hybrid Mode), the Cardiosave will not be able to charge the battery(ies) inserted and may affect the ability to safely transport a patient.
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 533 complaints, including 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, Getinge/Maquet/Datascope sent all affected customers an Urgent Medical Device Correction letter (described as “Issue 1: Docking/Power Battery Failure”).
The letter requested customers to follow these instructions if the Cardiosave IABP is seated in the cart but the AC Plug Icon is not present and/or the Rescue Icon is present:
- Release the latch on the Hospital Cart located below the Pump Console, then grab the handle and slowly slide out the console approximately one quarter of the way.
- Grab the handle and slowly slide the Pump Console into the Hospital Cart until it locks into place. You will know that the console is locked into the Hospital Cart when you hear an audible click noise and three audio tones of increasing volume.
- Confirm AC operation by checking that the Hybrid Icon (see below picture) is present in the top center of the lower display and that the AC Plus Icon is present in the lower right corner of the upper display.
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).
- 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.