After quiet Q4, device recalls surge in 2012
Recalls of medical devices jumped 160% between the fourth quarter of 2011 and the first quarter of 2012, a not entirely unexpected development after 2011's late-year tranquility, reports the ExpertRECALL Index.
The FDA recalled 277 devices in the first quarter, affecting 82 million units, the most in 5 quarters. While that number is high, the quarter-to-quarter increase wasn't terribly jarring to industry watchers, according to ExpertRECALL, because Q4 of 2011 was unprecedentedly quiet on the recall front, with 106 devices recalled.
"However, what is troublesome is the dramatic increase in units affected by the recalls and continued number of repeat offenders," said Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL, in a statement. "It's scary to think about, given the increasing number of devices that American patients rely on to maintain and improve their health."
One-third of the companies affected by recalls in Q1 had gone through the process before, including Covidien ($COV), which voluntarily recalled Duet TRS after the device led to 13 serious injuries and three deaths. The same went for St. Jude Medical ($STJ), which pulled its Brio DBS device off the shelves when it ceased to work in many patients, a recall that took place just months after one for Riata, the company's malfunctioning defibrillator.
The quarter's boom in device recalls stands in contrast to those in pharma, which decreased by 29% in Q1, ExpertRECALL notes.