Serious problems with the HeartWare heart pump.

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The Big Story
Fri. Jan 7, 2022

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A High-Risk Medical Device Didn’t Meet Federal Standards. The Government Paid Millions for More. <[link removed]> 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. by Neil Bedi

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More From This Investigation

“Get This Thing Out of My Chest” <[link removed]> 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. by Neil Bedi and Maryam Jameel <[link removed]>

Making Life-or-Death Health Care Decisions <[link removed]> 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. by Karim Doumar <[link removed]>

Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous <[link removed]> 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. by Neil Bedi <[link removed]>

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