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Congress opens investigation into FDA’s handling of a problematic heart device
The FDA took no decisive action even as safety problems with the LVAD persisted.
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A high-risk medical device didn’t meet federal standards. The government paid millions for more
For years after federal inspectors found serious problems with the HeartWare heart pump, agencies like the Department of Veterans Affairs and...
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Thousands of patients were implanted with heart pumps that the FDA knew could be dangerous
Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and...