“It sounded like a cement mixer.” This is how one Medtronic HeartWare HVAD patient described the sound coming from deep within his chest after the device became clogged with a blood clot. Years after the initial recall was ordered under a Class I status by the FDA, thousands of patients across the country are faced with a life-threatening dilemma: do they keep the device and hope it doesn’t fail them or do they undergo life-threatening surgery to remove it?
The Heartware HVAD has had problems almost since its initial release onto an unsuspecting public. First recalled as far back as 2016, that recall was based on evidence that the device’s external control unit could be adversely affected by moisture. Effects of such moisture varied, with some units failing to make an audible sound if the device entered an alarm state. Other devices failed completely, essentially flipping the switch on the only thing circulating blood through the wearer’s body.
2022 saw an additional recall of the Heartware, this time over concerns that the device could short circuit inside the patient’s chest. Fatality reports from these events were horrific. One patient’s family was forced to watch helplessly as they collapsed to the ground and began vomiting blood. An autopsy on one of the over 3,000 victims of Heartware failure showed charring on the patient’s heart at the site of the short circuit that took their life. In total, 15 recalls of the HVAD have been issued since its release.
Medtronic acquired the company behind the Heartware HVAD in the midst of a series of warnings and letters issued by the FDA. Unfortunately for those whose lives ended prematurely as a result of the device, those letters and warnings were the extent of the action taken by the agency. In fact, the FDA’s reaction to the risks posed by the Heartware HVAD was so weak that the agency itself came under Congressional investigation over its lack of urgency and action. To date, Heartwares have been implanted in over 19,000 patients, and they must live every day with the knowledge that the electronic device implanted in them could fail at any moment.
A post from ProPublica details the day-to-day anxiety that these people face. Some didn’t even find out about the recalls from the company that put them at risk. Facebook groups and other online posts were the first time that many found out there could be an issue with the Heartware HVAD, and their lives have never been the same since.