A BBC investigation has uncovered serious concerns about the use of the HeartWare HVAD ventricular assist device in NHS cardiac and transplant centres, even after data showed significantly worse survival rates than alternative devices.
The report, broadcast across multiple BBC platforms, raises questions about governance, safety oversight, and patient transparency within NHS England’s cardiac and transplant services, with particular scrutiny of Newcastle’s Freeman Hospital and Harefield Hospital in London.
Alarming data ignored
Ventricular assist devices (VADs) are mechanical pumps that help patients with advanced heart failure while awaiting transplant or further treatment.
In October 2018, NHS Blood and Transplant (NHSBT) audited the performance of two such devices — the HeartWare HVAD, made by Medtronic, and the HeartMate 3 (HM3), made by Abbott. The findings, shared among transplant centres, revealed stark differences:
- 1-year survival: HVAD 64.9% vs HM3 87.6%
- 2-year survival: HVAD 48.8% vs HM3 82.9%
- Freedom from stroke at 2 years: HVAD 71.9% vs HM3 92.0%
Despite these results, some hospitals continued using the HVAD until Medtronic withdrew it globally in June 2021, citing safety concerns related to device malfunction, stroke, and mortality.
The Medicines and Healthcare products Regulatory Agency (MHRA) had approved the device after a 2019 analysis, but it was not informed of the NHS data at the time.
NHS centres split over action
The BBC found that transplant centres reacted differently to the audit.
- Royal Papworth Hospital in Cambridge stopped using the HVAD in early 2018, citing clinical trial evidence showing the HeartMate 3 was superior.
- Freeman Hospital and Harefield Hospital, however, continued to use the HVAD, questioning the reliability of the audit data. Harefield relied solely on the Medtronic device until early 2021, just before the manufacturer’s safety notice.
Freedom of Information data later revealed that between October 2018 and June 2021, mortality for HVAD patients was two-and-a-half times higher than for those implanted with the HeartMate 3.
Freeman Hospital said it was aware of the data in 2019 but considered it “scientifically unreliable” because it had not been published in a peer-reviewed journal. Harefield commissioned an external review, but the report made no comment on device selection.
Device risks and global withdrawal
The HeartWare HVAD System, a centrifugal continuous-flow pump with magnetic and hydrodynamic bearings, had been implanted in about 20,000 patients worldwide. It received FDA approval in 2012 for bridge-to-transplant use and in 2017 for destination therapy. However, concerns grew over neurological events and higher mortality compared with newer devices.
In the UK, between 2018 and 2021, around 80 patients received the HVAD at Newcastle or Harefield hospitals. Three-year mortality was approximately 49% for HVAD compared with 19% for HM3, and many survivors experienced long-term complications from device-related strokes.
Calls for independent inquiry
Robbie Burns, former Chair of the Cardiothoracic Transplant Patient Group (NHSBT, 2022–2025), is urging an independent national review modelled on the Cumberlege “First Do No Harm” Inquiry.
He said the review should examine:
- How HVAD data was gathered, shared, and acted upon
- Decision-making within NHS transplant centres
- Oversight roles of NHS England and the MHRA
- Whether patients and families were properly informed about comparative risks
“This is not about blame; it’s about accountability, learning, and ensuring no other patient or family experiences the same distress,” said Mr Burns.
“When audit data shows one device carries a threefold mortality risk, it should not take years — and a BBC investigation — for the system to act.”
“Families deserve answers and reassurance that lessons are being acted on.”
Key recommendations
A stakeholder briefing shared with MPs, NHS England, and the Department of Health and Social Care outlines five immediate steps:
- Independent review of VAD governance, oversight, and patient communication.
- Creation of a National VAD Registry to monitor outcomes and complications.
- Stronger NHS England accountability for device safety decisions.
- Improved consent frameworks requiring full disclosure of performance data.
- Annual MHRA safety report to Parliament covering post-market surveillance.
Wider implications
The case exposes weaknesses in how NHS England evaluates and monitors new medical devices. It also highlights the need for better data transparency and faster response to emerging safety evidence.
Medtronic said patient safety remains its top priority and confirmed that it notified clinicians in June 2021 to cease sales and distribution of the device.
The Health and Social Care Select Committee, chaired by Layla Moran MP, is being urged to hold an inquiry into medical device governance and patient safety — a move that could lead to systemic reforms similar to those proposed in the Cumberlege review of 2020.
As debate grows over medical device regulation, the BBC investigation serves as a warning of the human cost when safety evidence is ignored and accountability falters.