Device Correction Issued for HeartMate Monitor Due to Potential Pump Stoppage

Abbott Medical has issued a device correction for its HeartMate left ventricular assist system monitor in response to screen issues that can lead clinicians to accidentally stop the pump, according to an alert from the US Food and Drug Administration. The agency has identified this as a Class I recall, the most serious type.

Issues like freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and wrong or missing information on the display “can cause a clinician user to inadvertently change pump settings or press the pump stop button,” the FDA said Friday. “The use of affected products may cause serious adverse health consequences, including decrease in blood pressure and inadequate flow of blood (hemodynamic compromise) caused by a pump stop. This can lead to stroke, irreversible brain damage, heart or organ failure, and death.”

There have been 14 injuries, but no deaths, tied to the issue. Abbott Medical’s corrective action  does not involve removal of any devices from the market.

The company alerted customers of the potential problems with the HeartMate system monitor in an Urgent Medical Device Correction letter on May 8, 2024. It detailed how to respond to the issue, saying that restarting the monitor should correct it in most cases.

Users should restart the monitor before connecting it to the patient controller if it has been on for a long time, or has previously demonstrated glitches. If screen issues continue after a restart, clinicians should then make sure nothing is wrong with the cables and connections. And if problems persist at that point, a different monitor should be used, according to the manufacturer.

The FDA alert notes that if the “stop pump” button is accidentally pressed due to problems with the monitor screen, the pump will stop only momentarily before restarting, unless the button is pressed for longer than 10 seconds. That will trigger the “pump off alarm,” at which point users should press any button on the controller to try to get the pump going again.

This device correction applies to all system monitors with the following unique device identifiers: 00813024010142 and 00813024010852.

The HeartMate system has been subject to multiple prior recalls this year, with one related to the touch communication system in March, another due to the potential for outflow graft obstruction in April, and one related to the risk of blood leaks or air in the system in May.