Abbott Issues Recall of Heartmate LVAD Communication System After Safety Risks

Abbott’s recent recall of its Heartmate LVAD communication system has received attention from the healthcare industry due to the potential risks associated with the device. The recall was initiated by Abbott after discovering a flaw in the communication system that could unexpectedly cause the Heartmate 3 left ventricular assist device (LVAD) to stop or start, posing serious health consequences for patients. The Food and Drug Administration (FDA) has classified this as a Class I recall, indicating the highest level of concern due to the potential for serious injuries or death.

The Heartmate LVAD, acquired by Abbott in 2017 through the purchase of St. Jude Medical, is a mechanical circulatory support for patients with end-stage heart failure, often acting as a bridge to heart transplant. Abbott’s dominance in the U.S. LVAD market intensified after Medtronic withdrew its competing pump in June 2021 following a series of recalls. The FDA urged healthcare providers to opt for Abbott’s Heartmate 3 LVAD as an alternative, emphasizing concerns over adverse events associated with Medtronic’s Heartware device. While Abbott’s device offers life-extending benefits, it is not without risks. Potential adverse events linked to the Heartmate 3 system include death, bleeding, right heart failure, respiratory failure, device malfunctions, stroke, and heart attack. Despite these risks, Abbott assured stakeholders of the device’s safety, highlighting that there were no reports of patient harm associated with the recall issue. Abbott is currently working on developing and releasing a software update to rectify the problem.

The recall specifically targets version 1.0.32 of the Heartmate Touch communication system, which is used in hospitals to monitor patients with the Heartmate 3 LVAD during implant procedures or other situations requiring close monitoring. Abbott notified physicians of the issue on January 3, 2024, following reports of complaints regarding the controller and an application error that could lead to unintentional starting or stopping of the Heartmate device. The FDA outlined the serious nature of the problem, particularly during implant or explant surgeries where extended procedure times pose heightened risks. This communication system is necessary for providing clinicians with real-time data on a patient’s cardiovascular status, allowing for timely interventions and adjustments during procedures. The potential for the system to inadvertently initiate or halt the Heartmate device poses serious risks to patient safety, especially during delicate surgical procedures where any disruption in circulatory support can have severe consequences. Healthcare providers are urged to implement the recommended protocols and remain vigilant in their use of the Heartmate LVAD system to safeguard patient well-being and minimize potential complications.

The recall affects 1,560 devices distributed in the U.S. between May 7, 2020, and December 18, 2023. It outlines the importance of following proper procedures outlined in the Instructions for Use to mitigate risks associated with the system. Abbott has advised healthcare providers to adhere to the recommended protocols, especially during the “STOP PUMP” sequence, and cautioned against disconnecting the Heartmate System Controller white cables or the Wireless Adapter prematurely. In response to the recall, Abbott has taken measures to address the issue, including issuing an Urgent Medical Device Correction Letter to affected customers and developing a software update to rectify the communication system flaw. Healthcare professionals are urged to stay vigilant and adhere to the updated instructions to ensure the safe use of the Heartmate LVAD system.