The FDA Calls Them ‘Recalls,’ Yet the Targeted Medical Devices Often Remain in Use - KFF Health News

Abbott issued a recall for its MitraClip cardiac device in 2016 .

Neither the manufacturer nor the FDA actually recalled the device or suspended its use.

Instead, Abbott revised instructions for use and required doctors who implant the clips to undergo training.

From 2019 through 2023 , there were 338 Class I medical device recalls, 164 of which were corrections.

Medtronic 's StealthStation S7 cranial software is an elaborate system of screens and other equipment that guides neurosurgeons using instruments in the brain.

In 2021 , the FDA issued a Class I recall for StealthStation , saying potential inaccuracies in a biopsy depth gauge could result in “life-threatening injury (such as hemorrhage, unintended tissue damage, or permanent neurological injury), which could lead to death.

The FDA lists the 2021 recall as still open.

Abbott 's MitraClip system includes tiny clips implanted in the heart’s mitral valve and equipment used to implant them.

In May , the FDA advised health care facilities to “transition away from these devices and seek alternatives, if possible” Abbott paused proactive marketing of the balloon pumps in the U.S. It is selling them only to customers who have no alternatives.