The FDA Calls Them ‘Recalls,’ Yet the Targeted Medical Devices Often Remain in Use

(By David Hilzenrath for KFF Health News)

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — “a Class I recall, the most serious type,” the FDA said.

“Use of this device may cause serious injuries or death,” an FDA notice about the recall said.

But neither the manufacturer nor the FDA actually recalled the device or suspended its use. They allowed doctors to continue implanting the clips in leaky heart valves in what has become a common procedure. Continue reading here…

Kaiser Health News is a nonprofit national health polity news service that is part of the nonpartisan Henry J. Kaiser Family Foundation

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