Understanding medical device recalls

At the Law Office of Richard Hay, we realize that many Kentuckians have undergone surgery to have a medical device implanted in their bodies, such as a pacemaker, stent, artificial hip, etc. Often these devices malfunction or fail, and when they do, their manufacturers or the Food and Drug Administration recall them. As the FDA points out, however, a recall may not necessarily mean that you must immediately rush to your doctor’s office demanding a new surgery to replace the recalled device.

A recall can mean one of the following three things:

  • The device may be defective.
  • The device may pose a health risk.
  • The device may be both defective and pose a health risk.

Correction recalls

If the device’s manufacturer or the FDA discovers that the device likely needs checking, adjusting or fixing, one of them will issue a correction recall. This means that you should obtain an appointment with your doctor as soon as possible so (s)he can check your device and make sure it is working properly. Many devices, including pacemakers, have batteries that occasionally need recharging or even replacement if they have reached the end of their usable life.

Removal recalls

If, on the other hand, the device’s manufacturer or the FDA discovers that the device is inherently dangerous and poses a serious health risk to anyone in whose body it was implanted, then the manufacturer or FDA will issue a removal recall. In this type of recall, the manufacturer generally notifies physicians of the problem and strongly recommends that they, in turn, contact their affected patients to discuss the medical and surgical risks of removing the faulty device as opposed to leaving it in place.

Be aware that while the FDA has the legal authority to force a manufacturer to recall its defective device(s), it seldom does so in practice. Rather, device manufacturers themselves issue the vast majority of recalls if and when they discover a problem and/or health risk associated with one of their products.

For more information, please visit this page of our website.