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.
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.
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. The FDA reviews the recall strategies that manufacturers propose and often provides input to ensure the public will be protected, Hils said. The agency also monitors the effectiveness of recalls and, before terminating them, makes sure the strategy was carried out, Hils said.
In a statement to KFF Health News, Medtronic spokesperson Erika Winkels said the safety and well-being of patients is the company's primary concern, and certain issues"can be safely and effectively remedied with a correction on site." In June 2023, Abiomed issued an urgent medical device correction for its Impella 2.5 intravascular micro axial blood pump, which supports the heart. In patients with a certain type of replacement heart valve, there was a risk of"destruction of the impeller blades," which could cause"low flow" and"embolization of the fractured impeller material," an
But, in May, the FDA changed its stance. The agency advised health care facilities to"transition away from these devices and seek alternatives, if possible." As a result of the FDA's May action, the company"immediately paused proactive marketing" of the balloon pumps in the United States, and it is selling them only to customers who have no alternatives, Frostehav said.Abbott's MitraClip system includes tiny clips implanted in the heart's mitral valve and the equipment used to implant them.
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