Posted in News on February 19, 2016
Some Montana residents might have a health or medical problem that is best addressed by a medical device. Such a device is often complex and must be in proper working order to ensure the health and well-being of the patient that is using it. If the medical device were to malfunction or if it ends up being defective, this could put the individual is serious risk of injury or even death.
When and how is a medical device recalled? A medical device is recalled when it is considered defective, could pose a risk to health by its users or when it is both defective and a risk to health. When a medical device is recalled, this does not mean that the patient using it automatically must stop using the product and return it to the company. In some cases, a medical device recall could mean that the device needs to be checked, adjusted or fixed.
Moreover, implanted medical devices do not always need to be removed when they are recalled. Sometimes there are greater risks with the removal of the device when compared to leaving it within the body. In these matters, certain action could be taken and may be considered a recall. The device could be inspected for problems, the device could be repaired, the setting on the device could be adjusted, the device could be re-labeled, the device could be destroyed, the patient is notified of the problem and the patient is monitored for any health issues caused by the device.
With regards to medical device recalls, there are two types of recalls — a correction or a removal. Either the device is corrected for the patient so they may continue to use it or the device is removed from them in order to avoid harm or risks.
In most of these recalls, a medical device company will make a voluntary recall when they become aware that the device violated FDA law. When this occurs, the company is required to recall the device though correction or removal and notify the FDA.
If a recall is not properly or timely completed and the medical device harms a patient, the injured patient might have recourses. A products liability action might be available, helping the injured party recover compensation for the person’s losses and damages.
Source: Fda.gov, “What is a Medical Device Recall?,” accessed Feb. 15, 2016