The U.S. Food and Drug Administration (FDA) categorizes medical devices into three classes based on the level of risk the devices pose to patients and users. Image Credit: IGORdeyka/Shutterstock.com ...

A medical device is any appliance, apparatus, software, material, or other articles, which may be used in isolation or combination (as defined by the manufacturer) by individuals for a medical purpose ...

In 2016, medical device giant Abbott issued a recall for its MitraClip cardiac device — "a Class I recall, the most serious type," the FDA said. "Use of this device may cause serious injuries or death ...