Abbott has issued a recall for the HeartMate Touch communication system (Version 1.0.32) that monitors patients with an implantable left ventricular assist device, the HeartMate 3, as the pump can unexpectedly stop or start.
In a notice posted on the U.S. Food and Drug Administration (FDA) website, it is explained that issues may arise when the HeartMate Touch system is disconnected from a patient’s HeartMate controller while a „stop pump“ command is being executed.
Upon reconnecting the HeartMate Touch to the same or a new controller, the pump will stop or start based on its status at the time of connection. There are no alarms or indications to warn the user that the „stop pump“ command is still in the command queue.
„The use of the affected system can have serious health consequences, including dizziness, sudden changes in blood flow, fainting, and death,“ says the FDA.
The FDA has classified this as a Class I recall, the most serious type, due to the risk of serious injury or death. Eight injuries and no deaths have been reported.
The recall affects 1560 HeartMate Touch communication systems distributed in the United States from May 7, 2020, to December 18, 2023.
This recall is a correction, not a product removal. Abbott has sent urgent corrective action letters to all affected customers with the following instructions to address the issue:
- Follow the instructions in the user manual, Chapter 4, HeartMate Touch communication system, pages 4-58 to 4-59, when performing the „STOP PUMP“ sequence.
- Only disconnect the white cables of the HeartMate System controller or the wireless adapter from the power supply module once the „STOP PUMP“ sequence screen with the red progress bar is no longer visible and the screen automatically changes.
- Do not disconnect the pump during the pump’s priming process until the timer reaches zero, the pump stops, and the message „Priming is complete“ appears.
Customers in the U.S. with questions regarding this recall should contact Abbott’s technical support at 1-800-456-1477.