FDA Issues Warnings About Safety Concerns Pertaining to Getinge/Maquet Cardiovascular Medical Devices

May 10, 2024
Two types of recalled devices have been the subject of many medical device reports, some involving serious injury or death to the patient.

The FDA has issued an alert to healthcare providers about safety concerns with certain Getinge/Maquet cardiovascular medical devices. The agency outlines its ongoing concerns with the devices in a press release.

Specifically, the FDA is recommending that healthcare facilities transition away from using Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and Getinge/Maquet Cardiohelp system and HLS Sets. The agency is concerned that “Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.”

Medical device reports keep coming in regarding these devices despite the fact that Getinge/Maquet “took corrective steps.” The FDA suggests reviewing their previous recommendations if it is necessary to continue using those devices.

The FDA is continuing to work with the Getinge to “understand factors contributing to the device failures, as well as possible mitigation strategies.” They have received 2,694 medical device reports pertaining to the Cardiosave IABP in the past 12 months alone, and 15 of those reports resulted in patient serious injury or death. Of 246 medical device reports pertaining to the Cardiohelp system and HLS set, 33 were reported as resulting in patient serious injury or death.