FDA identifies Abbott’s HeartMate TCS recall as Class I

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled product

• Product Names: HeartMate Touch Communication System
• Product Codes: See Recall Database Entry
• Distribution Dates: May 7, 2020 to December 18, 2023
• Devices Recalled in the U.S.: 1,560
• Date Initiated by Firm: January 3, 2024

Device use
The HeartMate Touch Communication System monitors patients who have an implantable HeartMate 3 Left Ventricular Assist Device. The HeartMate Touch Communication System works with the HeartMate System Controller. The system includes a tablet, wireless adapter, flash drive, power adapter, and USB. The system is used only by clinicians in hospitals or clinics to provide a detailed, large-scale display of a patient’s cardiovascular status. It can be used during implant procedures or whenever close monitoring of a patient is needed.

Reason for recall
Abbott is recalling their HeartMate Touch System (version 1.0.32) for risk of 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. 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.

The use of the affected system may cause serious adverse health consequences, including lightheadedness, sudden change in blood flow, loss of consciousness, and death.
There have been 8 reported injuries and no reports of death.

Who may be affected

• People who have the implantable HeartMate 3 Left Ventricular Assist Device.
• Health care providers who use the HeartMate Touch Communication System to monitor patients with HeartMate 3 Left Ventricular Assist Devices.

FDA