this post was submitted on 15 Aug 2024
15 points (94.1% liked)

Health - Resources and discussion for everything health-related

2198 readers
27 users here now

Health: physical and mental, individual and public.

Discussions, issues, resources, news, everything.

See the pinned post for a long list of other communities dedicated to health or specific diagnoses. The list is continuously updated.

Nothing here shall be taken as medical or any other kind of professional advice.

Commercial advertising is considered spam and not allowed. If you're not sure, contact mods to ask beforehand.

Linked videos without original description context by OP to initiate healthy, constructive discussions will be removed.

Regular rules of lemmy.world apply. Be civil.

founded 1 year ago
MODERATORS
 

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.

In a notice, the manufacturer explained, “Abbott is not removing product from commercial distribution.” Rather, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

When it comes to medical devices, recalls can include not only “removals,” in which the device is removed from where it is used or sold, but also “corrections,” which address the problem in the field — for instance, by repairing, adjusting, relabeling, or inspecting a device.

It’s very oxymoronic,” said Rita Redberg, a cardiologist at the University of California-San Francisco and former editor-in-chief of the journal JAMA Internal Medicine. “A recall makes it sound like it’s recalled. But that is not actually what it means.”

no comments (yet)
sorted by: hot top controversial new old
there doesn't seem to be anything here