FDA warns of continued cardiac pump safety concerns after series of recalls

Editor's Note

The US Food and Drug Administration (FDA) is urging healthcare providers to avoid using Getinge heart devices due to continued safety concerns that remain unaddressed despite previous recalls.

Issued to healthcare providers May 8, the warning letter applies to Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets. “The FDA continues to receive medical device reports (MDR) related to the problems even though Getinge/Maquet took corrective steps,” the agency reports.

The Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump IABP inflates and and deflates balloons in the aorta to provide temporary support to the heart’s left ventricle. The pumps have been the subject of 12 voluntary recalls, and there have been 15 reported incidents of death or serious injury out of 2,964 total medical device reports (MDRs).

The Cardiohelp 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, which is a disposable component of the Cardiohelp system. The system has been the subject of 8 recalls, and there have been 33 reported incidents of death or serious injury out of 246 MDRs.

“The FDA continues to work with the Getinge to understand factors contributing to the device failures, as well as possible mitigation strategies,” the agency reports.