MedTronic later bought HeartWare and began to implant the HeartWare Ventricular Assistance Device (HVAD), a medical device into patients with heart failure back in 2012. It seemed like a blessing. This device could keep patients' hearts pumping while they waited on a transplant.Even before regulatory approval was granted, problems started to appear. According to ProPublica's horrifying investigation, patients with the HVAD began to die. This was due to manufacturing defects that caused the batteries to fail, or static electricity buildup that short-circuited them altogether. ProPublica reports that even though the FDA, the regulatory agency responsible to keeping the medical device and pharmaceutical industries in line, knew of the issues and did not act or warn the public.According to ProPublicas investigation, more than 3,000 deaths were reported to the FDA by 2020.According to documents obtained by ProPublica, in June 2014, HeartWare CEO Dough Godshall received a warning from the FDA after learning of the defects. The FDA does not issue warning letters despite its mild name. This is because it only issues warning letters to medical device manufacturers who are committing serious safety violations or other violations of federal regulations.AdvertisementAdvertisementDespite the FDA's strong demands for a fix within 15 working days, HeartWare did not update or repair its HVADs. The FDA did not penalize HeartWare despite federal investigators finding multiple manufacturing problems with the HVAD. HVAD implants have been implanted in more than 19,000 patients. Most of these operations took place after the FDA sent its warning letter. HVAD was not stopped by the company, but it was recommended that HVAD be rescinded.The FDA did not inform the public, or HVAD-implanted patients, about the dangers associated with the device throughout the entire process.ProPublica was told by Rita Redberg, University of California San Francisco cardiologist, and expert in medical device regulation, that patients don't know and rely on FDA to protect them. How is it possible to not respond to a warning letter regarding these grave issues with very sick patients?
