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.
KFF Health NewsAug 15 2024 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.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.
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.
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. The FDA allowed the recalled MitraClip devices to remain in use "because the agency believed that the overall benefits of the device continued to outweigh the risks and the firm's recall strategy was appropriate and adequate," Harrison said.
Speaking of the MitraClip recalls, Redberg said, "So hard to imagine these are effective actions in protecting patients." 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 a September 2022 case, guidance provided by a StealthStation device was allegedly off the mark, a procedure was aborted, and, when the patient awoke, they "had almost no speech for two days," according to a Medtronic report. In the report, Medtronic said there was "insufficient information to determine the relationship of the software to the reported issue."
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 entry on the FDA website said.
The devices — which are placed in the aorta, a major artery, to assist the heart — were the subject of eight Class I recalls from December 2022 to July 2023. All were corrections rather than removals, a KFF Health News analysis found. "These recommendations are based on our continued concerns" that the manufacturer "has not sufficiently addressed the problems and risks with these recalled devices."
"We are working with the agency to finalize remediation and product update solutions," Frostehav said. In a news release at the time, Abbott said it had "received a small number of reports" in which that happened. The third MitraClip recall, initiated in September 2022, cited an "increase in clip locking malfunctions."
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