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recalled productsCBS News
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87% Informative
Medical device recalls that don't remove devices from the market have happened repeatedly in recent years .
FDA and federal regulations call these actions recalls, but they might be described more aptly as "non-recalls" From 2019 through 2023 , there were 338 Class I medical device recalls, 164 of which were corrections.
Medtronic 's StealthStation biopsy depth gauge could lead to "life-threatening injury," FDA says.
FDA lists the 2021 recall as still open, explaining "not all products have been corrected or removed" Another set of medical devices, Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps have failed persistently.
Abbott 's MitraClip system includes tiny clips implanted in the heart's mitral valve and the equipment used to implant them.
The company "immediately paused proactive marketing" of the balloon pumps in the U.S. It is selling them only to customers who have no alternatives, Frostehav says.
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