FDA Expresses Continuing Concerns About Getinge/Maquet CV Devices

Certain cardiovascular devices made by Getinge/Maquet remain problematic and should be avoided if possible, the US Food and Drug Administration said Wednesday in a letter to healthcare providers.

The agency has “continued safety and quality concerns” with the following devices: Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue intra-aortic balloon pumps (IABPs) and cardiopulmonary bypass devices including the Getinge/Maquet Cardiohelp system and HLS sets.

Though the manufacturer has taken steps to address previously identified problems, reports of issues continue to be submitted to the agency, said the FDA, which “recommends that healthcare 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.”

If alternatives aren’t available, users should review prior FDA recommendations and be aware of previous recalls.

These devices have been subject to numerous recalls over the past several years. Between January 2023 and April 2024, Getinge initiated 12 recalls of the IABPs, including eight categorized as Class I, the most serious type. The FDA said that over the past year, it has received 2,964 medical device reports related to the pumps, with 15 detailing serious injuries or deaths for patients.

The agency noted, too, that in March 2024, Getinge had its CE certification for the Cardiosave IABPs temporarily suspended in Europe for failing to fully implement corrective actions.

As for the Cardiohelp system and HLS set, Getinge initiated eight recalls between January 2023 and April 2024, with one categorized as Class I. The FDA received 246 medical device reports about the devices, with 33 involving serious injuries or death, over the past 12 months.

The FDA’s actions for Cardiosave IABPs began back in 2017, when the agency cited issues related to potential electrical test failure. Since then, there have been recalls referencing failure of the device valve (August 2017), fluid ingress (September 2017 and June 2018), failure at high altitudes (November 2018), potential battery failure (July 2019), battery problems (October 2021), fluid leaks (December 2021), blood flow into the pump (January 2023), unexpected shutdowns (March 2023), and again for the devices unexpectedly shutting off (August 2023).

“The FDA continues to work with the Getinge to understand factors contributing to the device failures, as well as possible mitigation strategies,” the agency said, adding that it “is working with other manufacturers to assess their interest and ability to manufacture and distribute alternative devices in the US.”