Abbott is recalling its HeartMate Touch communication system (version 1.0.32), which monitors patients with an implantable HeartMate 3 left ventricular assist device, for risk of unexpected pump stop or start. 

The HeartMate Touch communication system works with the HeartMate system controller. Issues may occur if the HeartMate Touch communication 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 eight reported injuries and no reports of death. The US Food and Drug Administration (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. 

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.

People who have the implantable HeartMate 3 left ventricular assist device and health care providers who use the HeartMate Touch Communication System to monitor patients with HeartMate 3 left ventricular assist devices may be affected.

Recalled product:  

  • Product name: HeartMate Touch Communication System 
  • Product codes: See recall database entry
  • Distribution dates: May 7, 2020, to Dec 18, 2023 
  • Devices recalled in the US: 1,560 
  • Date initiated by firm: Jan 3

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or fax. 

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