The FDA Calls Them ‘Recalls,’ Yet the Targeted Medical Devices Often Remain in Use - KFF Health News
Source: KHN
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…
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