When a company or manufacturer learns that one of their devices has a problem, a device recall will likely occur. Recalling defective medical devices does not always mean there is a serious health or injury risk. Sometimes the device simply needs to be examined, repaired or adjusted.
For patients, this means that an implanted device may not necessarily require removal. In some cases, the device may simply require a minor adjustment or repair to function safely and correctly. In all cases, patients should discuss any available options regarding the defective medical device with their physicians.
Companies that have discovered an issue with a device can initiate a recall on two fronts. They may issue a correction recall, which consists of addressing the problem in the marketplace, or a removal recall, which entails removing the defective medical device from the market altogether.
In most cases, the company or the manufacturer initiates the recall, but the FDA (U.S. Food and Drug Administration) may also recall a defective device. The FDA fills another important role as well. It reviews the company’s strategy for correcting the problem and it classifies the recall according to its degree of risk.
- Class I indicates a reasonable risk of death or serious health issues.
- Class II means there is a chance of minor health problems and a small risk of death or serious health issues.
- Class III indicates the device will likely not result in death or health issues.
Even though a defective medical device has been properly recalled, those who have suffered injuries from its use can still pursue compensation in Illinois and across the nation. In these cases, it is wise to speak with an attorney about which legal solution best meets your needs.
Source: U.S. Food & Drug Administration, “What is a Medical Device Recall?,” accessed Aug. 18, 2017