This recall, which aims to correct the issue without removing the products from the market, affects 1,560 devices distributed across the U.S. from May 7, 2020, to December 18, 2023. The decision for the recall was made after the company reported eight injuries but no deaths related to the problem.
The HeartMate Touch Communication System is used by clinicians to monitor patients with the HeartMate 3 left ventricular assist device (LVAD), a device previously lauded for its potential to extend the lives of patients with advanced heart failure by at least five years. The system, which includes a tablet, wireless adapter, flash drive, power adapter, and USB, provides detailed displays of cardiovascular status for use in hospitals and clinics.
The recall was prompted by the discovery that the system could malfunction if it disconnects from the controller while running a “pump stop” command, leading to unintentional stopping or starting of the pump upon reconnection. This malfunction could result in serious health consequences, including lightheadedness, sudden changes in blood flow, loss of consciousness, and potentially death, due to the absence of alarms or indications to alert the user of the pending command in the queue.
Abbott has issued specific instructions for the use of the device to mitigate these risks, advising against disconnecting the controller’s white cables or wireless adapter from the power module during a “stop pump” sequence until certain visual confirmations on the device are observed, as well as cautioning against disconnecting the pump during priming until specified conditions are met.