Abbott has recalled the HeartMate Touch Communication System (version 1.0.32), which monitors patients with an implantable HeartMate 3 left ventricular assist device, because the pump may unexpectedly stop or start. 

A notice posted on the US Food and Drug Administration (FDA) website explains that issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a “pump stop” command is running. 

When the HeartMate Touch is reconnected to the same or a new controller, depending on the status of the pump at connection, the pump will either stop or start. 

If the pump was stopped at reconnection, the pump will restart. If the pump is running at reconnection, a pump stop will occur. There are no alarms or indications that warn the user that the “pump stop” command is still in the command queue.

“Use of the affected system may cause serious adverse health consequences, including lightheadedness, sudden change in blood flow, loss of consciousness and death,” the FDA says. 

The FDA has identified this as a Class I recall, the most serious type, due to the potential for serious injury or death. There have been eight reported injuries and no reports of death.

The recall includes 1560 HeartMate Touch Communication Systems distributed in the United States from May 7, 2020 to December 18, 2023.

This recall is a correction, not a product removal. Abbott has sent all affected customers an urgent medical device correction letter with the following guidance on how to handle the problem:

• Follow instructions for use chapter 4 HeartMate Touch Communication System, pages 4-58 to 4-59 when performing the “STOP PUMP” sequence. 
• Do not disconnect the HeartMate System Controller white cables or the Wireless Adapter from the Power Module until the “STOP PUMP” sequence screen with the red progress bar is no longer visible and the “STOP PUMP” screen changes automatically. 
• Do not disconnect the pump during pump priming until the timer reaches zero, the pump stops and the “Priming is complete” message appears. 

Customers in the United States with questions about this recall should contact Abbott Technical Support at 1-800-456-1477.