Abbott’s problems with its HeartMate LVADs continue to grow, this time involving system monitors.
In an urgent field safety notice recently published in Germany, Abbott (NYSE: ABT) said it has received 299 complaints of the HeartMate system monitor screen displaying atypical behavior. The company added that there have been no reports of serious adverse health consequences.
The complaints included 22 reports of extended surgery time because of the need to restart or replace the monitor with a backup and 13 instances when the monitor had a display issue that resulted in the “stop pump” command being accidentally selected and the LVAD stopping momentarily and automatically restarting. Patients did not report symptoms from the momentary stops.
The latest urgent field safety notice comes as Abbott is working through Class I-level recalls in the United States involving blood leakage or air entering the seal interface between the left ventricular assist device (LVAD) inflow cannula and the apical cuff during the implantation of the device. There’s also a serious recall involving extrinsic outflow graft obstruction (EOGO), plus a HeartMate Touch System recall.
In a statement provided to MassDevice, Abbott said: “HeartMate 3 has set the standard for clinical outcomes associated with LVAD therapy, and recent quality updates by Abbott have been designed to alert physicians to new insights that can help them implant the device safely while offering optimal care post-implant.”
According to Abbott, the system monitor problem could result in hemodynamic compromise if pump settings are accidentally altered. Abbott is advising health providers that restarting the system monitor should resolve the problems in most cases and that they should use a different monitor for the patient if the restart does not resolve the issues.
In addition, Abbott already has a next-gen HeartMate Touch communication system. The company no longer supports and services the system monitor for managing HeartMate 3 and HeartMate II patients with the system controller. According to the company, the system monitor should not be used to manage patients on the HeartMate 3 and HeartMate II LVAD systems that are supported by the system controller.
Abbott’s recall problems with the HeartMate LVADs could present more hurdles for the adoption of the technology, which has proved challenging.
Abbott says research has shown that its HeartMate 3 pump can extend the lives of advanced heart patients by at least five years. The company’s HeartMate pumps are currently the only LVADs on the U.S. market. Medtronic stopped selling its HVAD in June 2021 due to mounting issues with the platform.
