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What Is a Medical Device Recall?

As San Diego product liability attorneys, patients often ask us what it means when a medical device is recalled. Given that the devices are intended to improve health, we can understand why it can be concerning to learn there may be a problem.

Medical device recalls are initiated when a device is found to violate U.S. Food and Drug Administration regulations. This may mean that the medical device is defective, it poses a risk to health, or it is both defective and a risk to health.

In most cases, the device manufacturer voluntarily recalls the device. When a company recalls a medical device, it:

  • Notifies the customers who received the product from them, and takes steps to reach others who need to be notified (for example, by issuing press releases or providing detailed instructions);
  • Provides information to help users identify the product and take steps to minimize health consequences; and
  • Takes steps to prevent the problem from happening again.

The role of the FDA is to oversee the recall to make sure that the actions the company takes are adequate to protect the public health. In addition, if a device maker fails to recall a device on its own, the FDA will often step in. For example, if a company refuses to recall a device that is associated with significant health problems or death, the FDA can compel the company to recall the device.

For patients, a medical device recall does not always mean that you must stop using the product. In many cases, the medical device just needs to be checked, adjusted, or fixed. If an implanted device like a pacemaker is recalled, it does not always have to be removed. Rather, patients are often instructed to contact their doctor to discuss the risk of removing the device compared to the risk of leaving it in place.

Of course, there are some cases where defective medical devices lead to serious complications and other health problems. When this happens, it is advisable to consult with an experienced lawyer to determine if you may be eligible for compensation.

If you or someone you care about has been seriously injured by a dangerous or defective medical device, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.