The FDA recently labeled a recall of Abbott
(NYSE: ABT)
HeartMate system monitors Class I, the most serious kind of recall.
HeartMate, a left ventricular assist device (LVAD), helps the heart pump blood when it fails to pump blood effectively on its own. The devices work by mimicking the pumping function of the heart’s left ventricle.
According to the FDA, HeartMate system monitors may display atypical behavior, including overlapping screens/buttons, frozen screens, distorted text, blanks or zeroes in place of values. Users may also face unresponsive buttons that can lead to inconvenience, hemodynamic compromise, extended surgical time and pump stop.
Abbott initially warned of this issue last month. The warning said the company received 299 complaints of the monitor’s atypical behavior. Abbott received no reports of serious adverse health consequences. It marked the latest of the company’s HeartMate problems, which included Class I recalls of certain systems in both April and May.
The company advised clinicians to restart the system monitor if faced with the issue. Restarting that monitor should resolve the issues “in most cases,” according to the FDA database. If issues persist after restarting, users should check all cables and connections to make sure they remain secure and undamaged. Beyond that, if issues continue, users should utilize a different system monitor.
If the issue leads to the inadvertent pressing of the “stop pump” button, the pump will stop momentarily and restart. If the button is pressed longer than 10 seconds, the pump will stop and tehe controller will alarm “pump off alarm.” Clinicians can press any button on the controller to attempt pump start to resolve this.
