Analysis finds cardiac devices recalled for safety reasons infrequently subjected to premarket or postmarket testing

A cross-sectional study of cardiovascular devices subject to Class I recalls from 2013 through 2022, found that most recalled devices did not undergo clinical testing before authorization and were not required to undergo postmarket surveillance studies. Even when premarket clinical testing was conducted, there was often a lack of evidence to support their original authorization.

These findings have important public health implications because recalls affect thousands of patients each year. The study is published in Annals of Internal Medicine .

Researchers from Harvard Medical School, Yale School of Medicine, and the University of California, San Francisco performed a cross-sectional analysis of all Class I recalls involving cardiovascular devices from 1 January 2013 through 31 December 2022 using data from the FDA's annual log to characterize the device recalls and the clinical evidence supporting their initial authorization.

The researchers found that there were 137 Class I recall events affecting 157 unique cardiovascular devices during the study timeframe. About 71% of the recalls were for moderate-risk 510(k) devices and about 28% were for high-risk premarket approval (PMA) devices.

Only about 19% of the recalled devices underwent premarket clinical testing and evidence was usually generated from a single nonrandomized, unblinded clinical trial using surrogate measures with no active control.

According to the study authors, these findings illustrate the limited clinical evidence supporting the use of cardiovascular devices later found to have serious safety concerns.