The FDA deemed a recall of the Abbott
(NYSE: ABT)
HeartMate Touch Communication System Class I, the most serious kind of recall.
Abbott warned of the potential for its HeartMate Touch System to unexpectedly stop or start. This recall is a correction, not a product removal, according to the FDA. The company reported eight injuries and zero deaths related to this recall.
In total, the recall affects 1,560 devices in the U.S. distributed between May 7, 2020, and Dec. 18, 2023. Abbott initiated the recall on Jan. 3, 2024.
The HeartMate Touch Communication system monitors patients who have an implantable HeartMate 3 left ventricular assist device (LVAD). Abbott has previously reported that HeartMate 3 can extend the lives of advanced heart failure patients by at least five years.
HeartMate’s communications system works with a controller and includes a tablet, wireless adapter, flash drive, power adapter and USB. Only clinicians in hospitals or clinics use the system to provide a detailed display of cardiovascular status. They can use it during implant procedures or whenever they need to closely monitor patients.
The company initiated its recall because issues can occur if the Touch System disconnects from the controller while running a “pump stop” command. When HeartMate Touch reconnects to the same or a new controller, depending on the status of the pump once connected, it will either stop or start.
If stopped at reconnection, the pump restarts. If running, a pump stop occurs, Abbott said. No alarms or indications exist to warn the user that the “pump stop” command still sits in the command queue. Using the affected system may lead to serious adverse health consequences. That includes lightheadedness, sudden change in blood flow, loss of consciousness and death.
Abbott instructed users to follow the instructions for use when performing the “stop pump” sequence. Users should not disconnect their controller white cables or 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. Additionally, they should not disconnect the pump during priming until the timer reaches zero, the pump stops and a “priming is complete” message appears.