According to trade press and the Food and Drug Administration (FDA), the number of high-risk Class 1 medical device recalls skyrocketed to the highest point ever in 2010, nearly doubling from 23 in 2009 to 51 in 2010, a 122 percent increase.
Class 1 is FDA’s most serious recall category, reserved for situations where the agency believes patients face a reasonable probability of serious injury or death. Years ago, when I was in FDA’s Public Affairs Office, there were only a handful of Class 1 recalls for the entire agency in a year. In contrast, in 2010, Bectin Dickinson and Cardiac Science tied for having the most Class 1 recalls with three each.
Back in the day, the Class 1 recalls that did arise were usually tied to fatalities. Take for instance, the Bjork–Shiley heart valve which became the subject of a famous lawsuit and recall after it was shown to malfunction with dire results. Today, there are many different scenarios in which a Class 1 recall may occur.
What could have caused this astronomical growth in Class 1 recalls? There are differing viewpoints. Having spent more than 17 years at the FDA, and many years since consulting with manufacturers on their interactions with the agency, I see several factors coming into play here.