The FDA and medical device manufacturers often allow doctors to continue using equipment that could potentially harm patients despite issuing recalls. This is highlighted in a case of the MitraClip cardiac implant, where although a Class I recall was issued in 2016, doctors were still allowed to use the device with revised instructions. Medical device recalls can include “removals” and “corrections”, but the decision to remove a device from the market depends on the severity of adverse events and the benefits and risks of patient access to the device. Despite concerns, some devices remain on the market with only minor fixes.
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Unpacking the FDA’s Non-Recall Recalls
