In 2016, medical device giant Abbott issued a recall for its — “a Class I recall, the most serious type,” the FDA said. “Use of this device may cause serious injuries or death,” an about the recall said. This story also ran on .
It can be . If you’ve had an experience with a medical device and would like to tell KFF Health News about it, to contact our reporting team. 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. , 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.” Though the FDA and call these actions , they might be described more aptly as “ .” And they have happened repeatedly in recent years.
For instance.