Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump.

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The Big Story
Thu. Aug 5, 2021

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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

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Tell Us About Your Experience With Life-Sustaining Medical Devices <[link removed]> 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. by Neil Bedi, Maryam Jameel and Maya Miller <[link removed]>

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