Abbott Recalls HeartMate Touch System

Abbott is recalling its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start. “Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a ‘pump stop’ command is running,” a recall notice says. “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 device pump will restart, the notice says. If it is running at reconnection, a pump stop will likely occur. “There are no alarms or indications that warn the user that the ‘pump stop’ command is still in the command queue,” it says.

The recall notice says that using an affected device may cause serious adverse events, including lightheadedness, sudden change in blood flow, loss of consciousness, and death. To date, there have been eight reported injuries and no deaaths.