Medtronic has released an update following a previous communication where the company identified a subset of HVAD pumps that may experience a significant delay to restart, or failure to restart.

Medtronic, after learning that some of its HeartWare HVAD heart pumps failed to restart, has released a backup controller with modified software to all hospitals that request it, according to an update from the Food and Drug Administration on Monday. 

While the backup controller can be used if the primary controller fails to restart the pump, the new software is not yet approved by the agency and has undergone limited testing, the company cautioned in an Oct. 13 letter to healthcare providers. 

Medtronic’s HVAD system includes a pump implanted near the heart as well as a controller to manage the pump’s speed and function. The device is used in end-stage heart-failure patients who are waiting for a heart transplant. The pump supports weak left ventricles and provides additional blood flow. Medtronic pulled the device from the market in June of 2021 after multiple recalls and reports of patient deaths.

Read the full article at MedTech Dive.