Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous. (ProPublica, Aug. 5, 2021) As HeartWare and Medtronic [which acquired HeartWare in 2016] failed inspection after inspection and reports of device-related deaths piled up, the FDA relied on the device makers to fix the problems voluntarily rather than compelling them to do so. The HeartWare Ventricular Assist Device [HVAD] was implanted into more than 19,000 patients, the majority of whom got it after the FDA found in 2014 that the device didn’t meet federal standards.
The HVAD was first approved for commercial distribution in November 2012.
In July 2015, human trials began for HeartWare’s second heart pump, the Miniaturized Ventricular Assist Device [MVAD]; at the end of July 2015, HeartWare stock sold for $90/share. These trials were halted after two months and only 11 implants; by mid-October, HeartWare was $35/share (setting the stage for Medtronic’s acquisition less than a year later). Some former HeartWare investors filed a class action lawsuit in January 2016 alleging deception in the development of the MVAD […] the suit alleges HeartWare promoted a life-sustaining medical device that former employees said had many problems and actually worsened blood flow, increasing clotting risks.
September 2017: the FDA approved the HVAD as “destination therapy” for patients who were not heart transplant candidates (relying on the device for the rest of their lives)
November 2018: Medtronic settled the investor suit for $54.5 million, admitting no fault
By December 31, 2020, roughly 3,000 death reports and 20,000 injury reports related to the HVAD had been filed with the FDA. On June 3, 2021, Medtronic stopped HVAD sales and implants. The company conceded that a competing device was safer after a new study showed the HVAD had higher rates of death and neurological injury. Medtronic also cited a 12-year-old problem with its devices not restarting if they disconnect from power, leaving patients’ hearts without support.
When Medtronic stopped the distribution and sale of the HVAD System in June, the HVAD had collected a total of 15 company-initiated “Class I” recalls for dangerous device problems that could cause injury or death. The others are “Class II” recalls (“a product may cause a temporary or reversible health problem or where there is a slight chance that it will cause serious health problems or death”), and the first notice is from July 2013.
By Medtronic’s tally, there are approximately 4,000 patients currently implanted with the HVAD worldwide.