FDA Recall: Risk of Unexpected HeartMate Pump Stop or Start

Company: Abbott
Date of Enforcement Report: 1/3/2024
Class I


HeartMate Touch Communication System (version 1.0.32)

Recall Number:



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.




1,560 devices distributed in the United States from May 7, 2020 to December 18, 2023.


Worldwide distribution. US nationwide, Australia, Austria, Canada, Colombia, Czech Republic, Germany, Hong Kong, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Martinique, New Zealand, Poland, Romania, Saudi Arabia, Singapore, Spain, Switzerland, Thailand and United Arab Emirates

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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