In 2016, while Abbott recalled the MitraClip device, it allowed continued use by updating guidelines instead of removing it, causing confusion about safety.
Rita Redberg noted, 'A recall makes it sound like it's recalled. But that is not actually what it means,' emphasizing the misleading nature of such announcements.
Despite the classification as recalls, many dangerous medical devices remain available, prompting concerns over whether regulatory actions sufficiently protect public safety.
The FDA's handling of medical device recalls contrasts with other safety agencies, which typically advise consumers to stop using such products immediately.
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