Getinge Cardiovascular Devices Again Under FDA Microscope

Getinge is once again under scrutiny from FDA related to the company’s cardiovascular devices. The agency today sent a letter to healthcare providers highlighting continued safety and quality concerns with the Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) and Getinge/Maquet Cardiohelp system and HLS sets after continued medical device reports (MDR) related to the devices.

But this isn’t Getinge’s first rodeo when it comes to scrapes with FDA pertaining to its cardiovascular devices.

Cardiosave IABP

From Jan. 1, 2023, through April 11, 2024, Getinge initiated 12 voluntary recalls for the Cardiosave IABP — eight of which were given Class I status. The device — which is placed in the descending aorta and used to inflate and deflate intra-aortic balloons for support in the hearts left ventricle through counter pulsation — has resulted in 2,964 MDRs sent to FDA in the last 12 months. Of those, 15 were reported as resulting in patient serious injury or death.

FDA has been evaluating and monitoring MDRs that describe Cardiosave IABP devices shutting down since 2017. Additionally, the agency has also been evaluating other concerns with the device such as blood entering the device, with can cause it to rupture, or patient or healthcare providers being exposed to patient blood.

And it isn’t only the United States acting on reported Cardiosave issues. On March 1, 2024, TÜV SÜD, the European Union notified body for certification services, temporarily suspended the CE certificate for the device with immediate effect. Getinge has six months from notification to adhere to the required corrective actions. During that period, Cardiosave IABP will not be sold in countries requiring CE certification.

Cardiohelp system and HLS sets

The other device highlighted in the recent FDA notification, the Cardiohelp system and HLS sets, also isn’t a stranger to FDA’s strong arm. In the same time period that Getinge also initiated its 2023 and 2024 Cardiosave recalls, the company initiated eight voluntary recalls for the Cardiohelp system, including the HLS sets. One of the eight recalls was also deemed Class I by FDA.

The system is a cardiopulmonary bypass device that pumps blood out of the patient to oxygenate the blood during cardiopulmonary bypass surgeries. The HLS set is an oxygenator and blood pump — a disposable component of the Cardiohelp system.

In the last 12 months, FDA received 246 MDRs related to the system and set, including 33 that were reported as resulting in patient serious injury or death. Additionally, in May 2023, FDA said that sterility of the product was a concern after the company notified customers that it removed another of its cardiopulmonary bypass devices, the Quadrox oxygenators, from the US market. The oxygenators continue to be unavailable due to sterility issues.

Continued concern

Now, FDA said it has continued concerns for the safety and quality of the two devices and is recommending that healthcare facilities transition away from use of the 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,” FDA wrote in the notice.

The agency also continues to receive MDRs related to the problems despite the company taking corrective steps, including reinforcing information in its instructions for use and providing users with new actions to take when using the IABP. FDA said it continues to work with Getinge to “understand factors contributing to the device failures, as well as possible mitigation strategies.”

Getinge manufacturing sites have been under consent decree from FDA and US Department of Justice since 2015, also adding the IABP site in 2022. The company has not yet met requirements to have the consent decree lifted.