Summary: The FDA advises transitioning away from Getinge Cardiosave and Cardiohelp systems due to safety concerns, while ECRI offers recommendations and information on alternative devices, including a Teleflex option for the Cardiosave and various alternatives for the Cardiohelp system.


The U.S. FDA recommends healthcare facilities transition away from Getinge Cardiosave balloon pump and Cardiohelp cardiopulmonary support systems due to safety and quality concerns. While the FDA didn’t suggest alternatives, ECRI is offering recommendations and information on alternative devices for adult patients.

Alternative Products

Only one FDA-cleared alternative to the Cardiosave is available, sold by Teleflex; various alternatives to the Cardiohelp system are available. We provide general specifications and pricing for the Teleflex device and several Cardiohelp alternative products in the following resources.

Resources for Download

ECRI Recommendations:

ECRI recommends facilities with affected Getinge devices comply with the FDA’s recommendations, plus take the following actions:

  • Assign device replacement planning to an appropriate facility committee, such as medical device, product evaluation, or value analysis.
  • If necessary, assign supervision of Getinge Cardiosave and Cardiohelp system use to an appropriate facility committee, such as perfusion, patient safety, or risk management.
  • For facilities with established adult ventricular assist device (VAD) programs, consider using a percutaneous VAD in suitable patients for short-term circulatory support instead of a balloon pump.

Inside these Devices

An intra-aortic balloon pump (IABP) is a mechanical device that helps the heart pump blood. IABP are used to treat patients that need emergency, short-term circulatory assistance. ECMO systems are life-sustaining systems used to treat patients that need short-term cardiopulmonary support.