Abbott Recalls HeartMate System Monitor

Release date:2024-06-12 Source: Author: Susan Kelly

### Dive Brief:


Abbott is recalling a system monitor used with the HeartMate cardiac pump due to screen display issues that may pose a risk to patients. The Class I recall affects 4,842 monitors distributed globally, according to a June 7 entry in the FDA database. In an urgent medical device correction letter sent to physicians in May, Abbott reported that no serious adverse health consequences had been reported and no devices were being pulled from the market.


This recall follows three earlier recalls this year related to the HeartMate left ventricular assist system, which is the only mechanical circulatory support device available in the U.S. after Medtronic ceased sales of its HeartWare pump in 2021.


### Dive Insight:


The HeartMate pump offers short- or long-term circulatory support for patients with heart failure by taking over the pumping function of the left ventricle. It can be used during heart recovery, while awaiting a heart transplant, or as a permanent implant.


In its communication to physicians, Abbott noted that all HeartMate system monitors could potentially experience screen display issues, which are typically resolved by restarting the monitor. However, Abbott cautioned that these issues might lead to hemodynamic compromise if the heart pump’s settings are accidentally altered, possibly resulting in insufficient blood flow. Despite the potential risk, no related complaints have been received.


From January 2012 to April 2024, Abbott received 299 complaints about the system monitor, including overlapping screens or buttons, unresponsive buttons, screen freezing, distorted text, and blank or zeroed values. Thirteen of these complaints involved the accidental selection of the “Stop pump” command due to display issues, causing the heart device to momentarily stop and restart, though no patient symptoms were reported. Additionally, 22 complaints mentioned extended surgical times due to the need to restart or replace the unit, while other complaints focused on user anxiety and inconvenience.


Abbott clarified that the HeartMate Touch, a newer system for managing HeartMate II and HeartMate 3 devices, is not affected by this recall. A company spokesperson stated that Abbott had advised physicians and clinics on how to handle the screen issues and recommended using the newer HeartMate Touch controller.


The previous three recalls of HeartMate devices this year did not result in product removal from the market. In March, Abbott recalled the HeartMate 3 system due to a sealing issue linked to 70 injuries and two deaths. In February, HeartMate II and HeartMate 3 systems were recalled because of potential biological material buildup obstructing the pumps, associated with 273 injuries and 14 deaths. In January, a version of the HeartMate Touch communication system was recalled due to the risk of unintentionally stopping or starting the pump, resulting in eight injuries.


Abbott acquired HeartMate through its purchase of St. Jude Medical in 2017, which had previously acquired the technology from Thoratec in 2015. HeartMate became the sole left ventricular assist device on the U.S. market in 2021 after the FDA recommended halting the use of Medtronic’s HeartWare device due to high rates of adverse events and mortality. Medtronic subsequently discontinued sales of the device.




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