FDA Urges Doctors to “Transition Away” from Certain Getinge Heart Pumps Due to Ongoing Safety Issues

Due to a shortage of alternatives to Getinge cardiovascular devices, the FDA has provided a series of recommendations for doctors who have to continue to using the products, which have been linked to patient injuries and deaths.

Federal officials are warning healthcare providers to stop using some Getinge cardiovascular devices, including intra-aortic balloon pumps, amid ongoing safety issues, which may be responsible for causing thousands of reports of side effects and dozens of patient deaths.

The U.S. Food and Drug Administration (FDA) issued a safety alert on May 8, indicating that doctors should stop using Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and Getinge/Maquet Cardiohelp system and HLS sets. Due to serious health risks for patients, medical providers are being urged to transition to other, safer, devices.

The Cardiosave IABP is a cardiac assist device placed in the artery in the chest or abdomen during cardiac surgery, which inflates or deflates intra-aortic balloons to temporarily provide support to the left ventricle of the heart of critically ill patients receiving care at a hospital or during transport to a medical facility.

The Cardiohelp systems are cardiopulmonary bypass devices that pump blood out of the patient to oxygenate it during surgery. The HLS sets are oxygenators and blood pumps used as disposable parts of the system during bypass surgery.

Each of the devices are crucial parts of heart surgery and provide lifesaving treatment to patients. However, the Geting cardiovascular systems have been plagued by ongoing reports of failure, recalls, and other problems.

The FDA first issued a medical device warning for Cardiosave IABP devices in 2019, expanding an initial recall for more than 5,000 devices first issued in 2018. From 2023 to April 2024, Getinge initiated 12 additional recalls for the IABP devices, eight of which were listed as class I, which is the most serious type of recall and suggests that continued use of the products poses a risk of serious harm or death to patients.

Following the Getinge heart pump recalls, the FDA continues to receive reports linked to problems affecting Cardiosave IABPs.

In the past 12 months, the agency received nearly 3,000 reports, 15 of which led to serious injury or death. The problems were reported even though Getinge initiated corrective steps for the devices. The European Union suspended certification for the devices completely.

The Cardiohelp and HSL sets are also plagued by similar device defect problems. From 2023 to April 2024, Getinge initiated eight recalls involving these devices, one was classified as class I.

In the past 12 months, the FDA received 246 medical device reports and 33 of those caused serious patient injury or death.

The FDA warning called on hospitals to transition away from using both devices and find alternatives. The agency also warned that alternative treatment options are limited and offered recommendations when doctors must continue to use the devices. The agency called for doctors forced to use the devices to:

• Review the FDA’s safety recommendations for continued use of the devices.
• Read the Urgent Medical Device Correction notices and follow the recommendations.
• Be aware of the recalls and the problems linked to the devices.

Medical professionals should also continue to report any problems or injuries linked to the devices to the FDA MedWatch Adverse Event Reporting program.