Some FDA-recalled medical devices remain in use while manufacturers implement corrections

Editor's Note

A 2016 recall issued for the Abbott MitraClip cardiac device highlighted potential safety concerns, but instead of removing the product from the market, Abbott and the Food and Drug Administration (FDA) allowed continued use with revised instructions and additional training for doctors. This approach reflects a broader trend in medical device recalls, where potentially dangerous products remain available under "corrections" rather than "removals," KFF Health News August 22 reports.

The FDA classifies recalls into two categories: removals, where a device is physically taken off the market, and corrections, where the issue is addressed without removing the device. While corrections can mitigate risks without disrupting patient access, they may also provide a false sense of security. Between 2019 and 2023, 338 Class I medical device recalls were issued, with about half being corrections.

Some devices, like Abbott's MitraClip, have undergone multiple recalls without being removed from the market. Despite these recalls, the FDA maintains the benefits of these devices can outweigh the risks, as long as corrective actions are implemented effectively. However, critics argue that this practice may not always adequately protect patients, especially when devices have recurring issues.

For instance, Medtronic's StealthStation, a neurosurgical guidance system, has been involved in recalls due to software errors but remained in use with temporary fixes. The FDA's recall strategy often balances risk with the necessity of keeping essential devices available for patient care, but this approach is not without controversy.

Abbott and other manufacturers defend their practices, citing the life-saving potential of their devices and ongoing improvements to address safety concerns. The FDA monitors these recall actions and evaluates their effectiveness before closing them. However, the decision to leave recalled devices in the market continues to raise questions about the adequacy of current recall strategies in ensuring patient safety.