HeartMate System Monitor Recalled by Abbott Due to Screen Problems

Abbott has recently recalled a system monitor used in the HeartMate cardiac pump due to issues involving the screen that can be dangerous for patients. This Class 1 recall involves 4,842 monitors shipped in the U.S. and internationally, as reported by the Food and Drug Administration (FDA).

Abbott’s urgent medical device correction letter to physicians in May clarified that no serious health issues have been reported and that the devices will remain on the market despite the recall.

The HeartMate system is vital for offering patients with heart failure short or long-term mechanical circulatory support. It helps the left ventricle, which is the main pumping chamber of the heart, and may be used to aid heart recovery, support patients waiting for a heart transplant, or provide permanent assistance. In its letter to physicians, Abbott explained that all HeartMate system monitors might suffer from screen display problems, but a restart can easily remedy the condition.

Abbott also pointed out that screen display issues can cause the heart pump settings to change, leading to inadequate blood circulation in patients. Fortunately, there have been no reports of complaints associated with this risk. From January 1, 2012, to April 30, 2024, Abbott has recorded 299 complaints concerning system monitors involving overlapping of the screen or buttons, unresponsive buttons, screen freezing, blurring of the written text, and zeros or blanks appearing instead of values. 

Complaints included that the “Stop pump” command was sometimes accidentally activated due to display peculiarities, causing a temporary cessation of pumping and a subsequent automatic resumption of operation. Most importantly, patients did not show symptoms when the pump failed to work. Furthermore, 22 reports were due to additional time required for surgery since the unit had to be reactivated or switched with another unit. Other complaints were mainly related to the stress or inconvenience of the customers.

The updated HeartMate Touch, a command center for HeartMate II and HeartMate 3 devices, is not part of this recall. An official from the firm disclosed that Abbott informed physicians and clinics on how to deal with the screen challenges and urged them to use the newer HeartMate Touch controller, which does not have screen complications.

This is the most recent recall for HeartMate devices this year. Previous recalls also targeted the same devices. In March, Abbott pulled the HeartMate 3 system due to a sealing glitch during implantation; this was connected to 70 harm incidents and two fatalities. In February, the HeartMate II and HeartMate 3 systems were recalled over the issue of biological material accumulation that can cause pump obstruction; this had 273 complications and 14 fatalities. In January, a model of the HeartMate Touch communication system was recalled due to a possibility of the pump stopping or starting on its own, resulting in eight cases of injury.

HeartMate was obtained by Abbott through the acquisition of St. Jude Medical in 2017. St. Jude had previously acquired this technology from Thoratec. In competitor analysis, HeartMate was the only left ventricular assist device available in the U.S. market in 2021 after the FDA advised doctors to cease implanting Medtronic’s HeartWare device due to a high incidence rate of adverse effects and mortality. J&J later pulled the device from the market following numerous reports of negative effects experienced by patients who used it.