In a revelation that’s left families grieving and the medical community reeling, two of the United Kingdom’s top transplant hospitals—the Freeman Hospital in Newcastle and Harefield Hospital in London—continued to use a heart device linked to significantly higher death rates, even after warnings from the NHS and mounting international concerns. The device in question, the HeartWare HVAD, manufactured by Medtronic, was implanted in dozens of patients with failing hearts, many of whom were either waiting for transplants or deemed ineligible for them. The consequences proved devastating for many, with nearly half of those fitted with the device dying within three years.
As reported by BBC and corroborated by the Daily Mail, the NHS first raised red flags about the Medtronic device in 2018. A preliminary audit in October that year—and a more detailed analysis in April 2019—painted a stark picture: 45% of the 119 patients who received the Medtronic HeartWare HVAD died within two years. By contrast, only 15% of the 97 patients fitted with the rival Abbott Heartmate III device died in the same period. The audits found no significant differences between the two patient groups, suggesting the device itself was the key variable.
Despite these findings, both the Freeman and Harefield hospitals continued to use the Medtronic pump for years, only ceasing after the manufacturer itself withdrew the device in June 2021. In the interim, more patients were fitted with the device, and the mortality gap only widened. Data released under the Freedom of Information Act revealed that between October 2018 and June 2021, 49% of patients who received the Medtronic device died within three years, compared with just 19% of those given the Abbott device.
Why did these leading centres persist in using a device with such troubling statistics? Hospital officials at both sites argued that their decisions were rooted in "complex clinical decisions" and that, at the time, there were "no clear grounds" to believe the Medtronic device was significantly inferior. The Freeman Hospital stated it regarded the NHS data as unreliable, pointing out it hadn’t been published in any national or international scientific journal. It also cited other publications that suggested the Medtronic device yielded "excellent outcomes." Harefield Hospital, for its part, commissioned an external review in 2019, which made no comment on its device selection.
Yet, the Royal Papworth Hospital in Cambridge took a markedly different approach. According to BBC reporting, Papworth stopped using the Medtronic device as early as February 2018, citing results from two randomised controlled trials and growing international unease. Its clinicians simply considered the Abbott Heartmate III superior.
The Medtronic device, known as a Left Ventricular Assist Device (LVAD), is a mechanical pump that helps weakened hearts circulate blood. For many, it’s the only hope of survival while awaiting a transplant. The device is implanted into the heart, with a wire connecting to an external controller and batteries. For decades, LVADs have been a lifeline for patients with advanced heart failure. But not all LVADs are created equal, as this tragic episode has made painfully clear.
One of the most heart-wrenching cases is that of Greg Marshall, a fit and ambitious young man from West Yorkshire who dreamed of joining the Royal Marines. After suffering acute heart failure in 2019, Greg was offered the Medtronic device by the Freeman Hospital—months after the NHS had already flagged its higher mortality risk. His mother, Tessa Marshall, recalls the shock: "It was a massive shock to us all." She says the family was not presented with the long-term risks associated with the device, only its potential benefits, as relayed by another patient.
Greg agreed to the surgery, but a significant complication led to a stroke, leaving him with impaired speech and paralysis on his left side. As he slowly recovered, tragedy struck again: in July 2020, the device stopped working and failed to restart. Terrified of another stroke, Greg refused surgery to remove the device, which remained inside him, switched off, as he waited for a transplant. In September 2023, while still on the waiting list, Greg went into cardiac arrest and died at just 26 years old. "I kick myself now, for not doing any more research," his mother lamented to the BBC.
According to the BBC, the Freeman Hospital has since expressed "sincere condolences" to Greg’s family and is investigating his case. The hospital also acknowledged it was aware of the NHS data in April 2019 but questioned its scientific reliability. The Medicines and Healthcare products Regulatory Agency (MHRA), which continued to approve the device after the 2019 analysis, had not been informed by the NHS of the audit’s findings.
Adding another layer of complexity, both the Freeman and Harefield hospitals were aware that some of their leading cardiologists were paid consultants for Medtronic, the device’s manufacturer. Public records show that Professor Stephan Schueler, who was responsible for Greg’s care and until recently headed the Freeman’s cardiothoracic department, had a decade-long relationship with Medtronic. Greg’s family claims that this relationship was never disclosed to them, despite requirements by the General Medical Council (GMC) for such transparency. Professor Schueler told the BBC, "there was never a financial incentive nor any salary arrangements with Medtronic for me or anybody else in our team to choose one device over the other." He added that all decisions were made collectively by a team of specialists and that he always acted within GMC standards.
It is not unusual for clinicians to act as consultants for medical device manufacturers, a practice that can foster innovation and improve patient care when properly managed. However, the lack of disclosure in this case has raised serious ethical questions. Robbie Burns, a patient representative with NHS Blood and Transplant who obtained many of the relevant documents, told the BBC, "It was entirely preventable. If I had been in the position of receiving this [Medtronic] device, and looked back at the data, I would be going, 'Why on earth did you do this?'"
Medtronic ultimately withdrew the device in June 2021, citing not only the higher frequency of strokes and deaths but also a specific malfunction: in some cases, the pump would delay or fail to restart after stopping. The company said patient safety was its "top priority" and that it continues to support the approximately 1,200 patients worldwide who still have the device implanted.
The story of the Medtronic HeartWare HVAD serves as a sobering reminder of the high stakes in medical device selection and the critical importance of transparency, timely data sharing, and patient consent. For families like the Marshalls, it’s a tragedy that demands not just answers, but genuine change in the way hospitals weigh evidence and communicate risk.
