Medical Device Recalls

Pursuant to a congressional request, GAO provided information on the overall characteristics of medical device recalls, focusing on those that: (1) involved medical devices that the Food and Drug Administration (FDA) approved through its pre-market approval process (PMA) for marketing and subsequently recalled; and (2) FDA classified as class I, the most serious health risk.

GAO found that: (1) 28 PMA-design and 48 class I recalls accounted for 4 percent of the 1,635 total recalls between 1983 and 1988; (2) six recalls fell into both groups; (3) although the combined recalls were a relatively small proportion of the total, they were among the most important from a public health perspective; (4) FDA either determined that devices involved in PMA-design recalls were unlike any other devices on the market or assigned them the highest risk category and passed them through its most stringent review for safety and effectiveness; (5) FDA reserved class I recalls for instances of patient death or potential serious adverse health consequences; (6) the most frequent causes of PMA-design recalls involved failure of the device to perform reliably and failure of the original process design to achieve its intended results; (7) although there were no actual adverse health consequences associated with the majority of recalls, about one-third of the PMA-design recalls and over half of the class I recalls involved at least one patient's injury or death; (8) the FDA recall databases could not store and aggregate all the available information about particular recalls and did not include the number of patient injuries or deaths associated with each product; (9) FDA learned of recalls from sources other than the manufacturer in over half the cases, because it did not require manufacturers to notify it of recalls; and (10) over half of all the recalls did not have the required device problem reports filed with FDA at the time of its evaluation.