When a manufacturer becomes aware of problems with one of its medical devices, it notifies the Food and Drug Administration (FDA) that one of two actions need to happen. The first is a correction, which deals with fixing a problem where the medical device is sold or used. The second is a removal, which involves removing the medical device from where it is sold or used.
Recalls occur when there is a risk to a person’s health, the medical device is defective or when both are the case. Just because a medical device is recalled, that doesn’t always mean that you must stop using it or that you have to return it to the manufacturer. It might mean that the device needs to be checked, fixed or adjusted.
Some of the actions that might take place because a medical device is recalled include:
- Repairing the medical device
- Inspecting the medical device for issues or problems
- Adjusting the medical device’s settings
- Destroying the medical device
- Letting patients know that there is an issue or problem with the device
- Continued monitoring of patients who have health issues because of the medical device
In most instances, the FDA is not who recalls a defective medical device. The manufacturer does. The FDA recalls devices when a manufacturer does not do so. However, if the manufacturer chooses to be responsible, it will initiate a correction or removal recall and then notify the FDA. The FDA will assign the recall a specific classification based on the degree of risk to patients.
If you have been injured or someone you love has died due to a defective medical device, you may have a right to seek compensation through a civil lawsuit. An experienced attorney can help you learn more about your legal options.
Source: Food and Drug Administration, “What is a Medical Device Recall?,” accessed Nov. 09, 2017