Medical Device Recalls Have Doubled in 10 Years | Shapiro, Washburn & Sharp

FDA reported this week that recalls of medical devices doubled from 2003 to 2012, according to a new report.

The total number of recalls increased to 1190 in 2012, which is a big increase from 604 in 2003. There was a big increase in recalls where the defective product had a ‘reasonable probability’ of death. In 2012, there were 57 of these, also known as Class I recalls. This was an increase from seven in 2003.




This analysis by the Center for Devices at FDA was done in part as a response to a report in 2011 by the GAO (Government Accountability Office). The report notes that recalls by many medical device firms often came too late to do any good for the product defects; thousands of the products already were implanted in the patients. A ‘recall’ means that the product is removed from the market, or is corrected in response to a defect.

One flawed medical device that was hard to recall was Medtronic’s Sprint Fidelis defibrillator wires in 2007. These devices would fracture in a small number of patients, which led to patient deaths. About 270,000 were implanted in patients before FDA announced the recall. Many of these devices were still implanted at the time.

Medtronic stated that it has a system in place where the doctor’s office monitors patients remotely to provide an early warning if a device is going to fail.

According to Steve Silverman, the director of the Office of Compliance at Center for Devices, some of the recalls stemmed from FDA inspections. Others followed a workshop done in 2010 that FDA held on cutting down on radiation exposure from X-rays and other related imaging tools. That workshop made hospitals more aware of the issue of high dosing, so more problems were reported.

Silverman was not able to give numbers of devices or patients that are affected by the recall. But he did state that the rate of recall is lagging industry growth. FDA stated that the total number of medical devices on the market have increased 25% in the last five years.