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Today, the U.S. Food and Drug Administration (FDA) is alerting health care providers and facilities about our continued safety and quality concerns with the following Getinge/Maquet cardiovascular medical devices:
- Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and
- Getinge/Maquet Cardiohelp system and HLS Sets.
The FDA recommends that health care providers and facilities transition away from these devices and seek alternatives, if possible. These recommendations are based on our continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.
Questions?
If you have questions about this Letter to Health Care Providers, contact the Division of Industry and Consumer Education (DICE).
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