News | FDA | March 12, 2024

FDA Announces Abbott Recall of HeartMate Touch Communication System for Unintentional Pump Start and Stop

The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling its 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. People who have the implantable HeartMate 3 Left Ventricular Assist Device may be affected.

The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling its 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. People who have the implantable HeartMate 3 Left Ventricular Assist Device may be affected.

The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling its 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. People who have the implantable HeartMate 3 Left Ventricular Assist Device may be affected.


March 12, 2024 — The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling its 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. People who have the implantable HeartMate 3 Left Ventricular Assist Device may be affected.

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.

Please be aware, this recall is a correction, not a product removal.

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.

What to Do 

In January 2024, Abbott sent all affected customers an Urgent Medical Device Correction LetterExternal Link Disclaimer.

The letter requested customers to:

Follow the 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. 

Contact Information 

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

Additional Resources

Medical Device Recall Database Entry

Firm Recall/Correction Letter External Link Disclaimer

How do I report a problem?

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.


Related Content

News | FDA

April 18, 2024 — Bayer AG and Asklepios BioPharmaceutical, Inc., a gene therapy company wholly owned and independently ...

Home April 18, 2024
Home
News | FDA

April 15, 2024 — The U.S. Food and Drug Administration (FDA) announced Abbott/Thoratec Corp. is recalling HeartMate II ...

Home April 15, 2024
Home
News | FDA

April 12, 2024 — Simpson Interventions, Inc., a pioneering medical technology company specializing in cardiovascular ...

Home April 12, 2024
Home
News | FDA

April 2, 2024 — Medical device technology developer Concept Medical has announced it has been granted Investigational ...

Home April 02, 2024
Home
News | FDA

April 2, 2024 — Abbott announced that the U.S. Food and Drug Administration (FDA) approved the company's first-of-its ...

Home April 02, 2024
Home
News | FDA

April 1, 2024 — Esperion announced that the United States Food and Drug Administration (FDA) has approved broad new ...

Home April 01, 2024
Home
News | FDA

March 28, 2024 — Medtronic plc, a global leader in healthcare technology, announced that the United States Food and Drug ...

Home March 28, 2024
Home
News | FDA

March 27, 2024 — Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has approved OPSYNVI – ...

Home March 27, 2024
Home
News | FDA

March 27, 2024 — Elixir Medical has announced it has been granted Breakthrough Device Designation by the U.S. Food and ...

Home March 27, 2024
Home
News | FDA

March 27, 2024 — Merck, known as MSD outside of the United States and Canada, announced that the U.S. Food and Drug ...

Home March 27, 2024
Home
Subscribe Now