August 20, 2024
by David Hilzenrath, Kaiser Health News
Credit: Unsplash/CC0 Public Domain
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.”
Though the FDA and federal regulations call these actions recalls, they might be described more aptly as “non-recalls.” And they have happened repeatedly in recent years. For instance, in addition to other Abbott devices, products made by Medtronic, Abiomed and Getinge have had recalls that left them in use.
Safeguarding the Public
Recalls that leave what the FDA identifies as potentially dangerous products in the marketplace can raise the question: Do they do enough to protect the public?
There are other ways to handle recalls. In announcements about products as varied as crib bumpers, pool drain covers, bicycle helmets and coffee mugs, the Consumer Product Safety Commission routinely alerts consumers to stop using recalled products and contact the manufacturers for refunds, repairs or replacements.
The National Highway Traffic Safety Administration regularly advises consumers to bring recalled cars back to the dealer to have them fixed. When the U.S. Department of Agriculture and the FDA announce food recalls, they routinely tell consumers to return or discard the food.
In some cases, a medical device that is the subject of a recall can be kept on the market safely because there is a simple fix, said Sanket Dhruva, a cardiologist and an associate professor at UCSF who has studied FDA oversight of devices. In other cases, recalls that don’t remove devices from the market can provide unwarranted reassurance and leave the public at risk, Dhruva said.
From 2019 through 2023, there were 338 Class I medical device recalls, 164 of which were corrections and 174 of which were removals, FDA spokesperson Amanda Hils said.
Some products undergo recall after recall while they remain on the market. Products in the MitraClip line have been the subject of three rounds of recalls, none of which removed devices from use.
Journal information: JAMA Internal Medicine
2024 Kaiser Health News. Distributed by Tribune Content Agency, LLC.
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