A life-sustaining device was implanted inside thousands of people, even though the federal government knew about serious problems.
The investigation follows ProPublica’s reporting on safety problems surrounding the FDA and the HeartWare Ventricular Assist Device.
For years after federal inspectors found serious problems with the HeartWare heart pump, agencies like the Department of Veterans Affairs and Centers for Medicare & Medicaid Services continued paying to implant it in patients.
A life-sustaining heart pump was taken off the market after years of problems and FDA inaction. Thousands of people are now stuck with it embedded in their hearts.
An investigation into quality problems with a heart pump shows how hard it can be for patients to get the information they need to make life’s most important health care decisions.
Do you or someone you know have a pacemaker, defibrillator, implanted prosthetic, or other lifesaving device? Do you work with or in the medical device industry? Help us report.
Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.