FDA: New Fix Available for Medtronic’s Troubled HeartWare VADs

The US Food and Drug Administration announced today that Medtronic has developed a software fix for subsets of its beleaguered HeartWare ventricular assist device (HVAD) system known to initially fail to start or restart with a delay after the pump is stopped.

While the HVAD is no longer commercially available—Medtronic stopped its sale and distribution following a series of complaints, patient deaths, and Class I recalls—the company is making a new algorithm available to address devices known to be affected. The algorithm is part of modified software deployed on the controller and is intended to help start the pumps should they fail to start or restart.

Medtronic initiated a Class I recall of the HVAD pump implant kit in December 2020 after learning about this specific problem. A delay in starting or a failure to restart can cause serious patient harm, including MI, worsening heart failure, the need for additional procedures and hospitalizations, and death.

In a letter to healthcare professionals, the company stressed that the algorithm addressing the problem is unapproved and “there is very little testing completed.” However, patients may have no alternative options if the standard controller fails to restart the HVAD pump. Two years after implantation, pumps in one subgroup of HVADs identified by Medtronic have a 21.8% cumulative probability of a failure/delay-to-restart event.  

“This unapproved controller software has not been approved as being safe or effective for use, which means it has not been tested to the same level as software that has been approved by the FDA,” according to the medical communication. “As stated earlier, this unapproved controller software should ONLY be used if the pump has stopped, and the standard controller is unsuccessful at restarting the pump. The long-term durability and functionality of a controller with the unapproved software is not yet known.”

While the algorithm was developed for patients who received devices from the manufactured lots known not to start, or restart only after a delay, the algorithmic fix is available for all patients on HVAD support, according to Medtronic. If physicians decide they want to have the controller with the programmed software available at their hospital, Medtronic will make it available at no cost.