Recalls occur when a medical device is defective and/or when it creates a potential health risk to public safety. When defective medical devices are used, serious injuries, complications, and fatalities are often seen by a defective medical device lawyer Reno NV.
Who Recalls Defective Medical Devices?
The U.S. Food and Drug Administration (FDA) oversees the safety of medical devices. In most cases, the manufacturer or distributor of a medical device voluntarily recalls the device when the device is defective and creates a potential health risk to the public. The company usually initiates a recall through correction or removal procedures and notifies the FDA of the recall. In cases where a company is aware of problems with a group of medical devices, but can’t pinpoint problems to one device, the company may recall all products within a model or product line. If a company refuses to recall a medical device that’s associated with significant health risks, injuries and fatalities, the FDA recalls the device.
When defective medical devices are recalled, it doesn’t automatically result in discontinued use of the device. In some recalls, the medical device is evaluated, checked, adjusted, or repaired. When implanted devices are recalled, they don’t always have to be removed from patients. If an implanted device has the potential to suddenly or unexpectedly fail, companies advise physicians to contact their patients and discuss the risks associated with removing the device or leaving it in place. If injuries occur, patients often seek financial damages through a defective medical device lawyer Reno NV.
How Does the FDA Notify the Public on Recalls?
When the FDA is notified on a company recall, the agency assesses associated health risks, determines if the defect violates FDA law, and assigns a degree of risk to the recall.
- Class I Recall – Indicates a situation where a product poses a significant potential risk for serious health problems, injuries or death.
- Class II Recall – Indicates a situation where a product may cause temporary health problems, or where there’s a small risk for serious health problems, injuries or death.
- Class III Recall – Indicates a situation where a product is not likely to cause any health problems or injuries.
Once the recall is classified, the FDA monitors the recall to ensure safety and posts information about the recall in the Medical Device Recall Database. When the recall is terminated, the FDA updates the database.