FDA advised to rethink recall language on heart devices

The wording of agency warnings was inflammatory and led to risky replacements of malfunctioning defibrillators, some doctors say.

By Kevin B. O'Reilly, AMNews staff. Nov. 6, 2006.

The Food and Drug Administration should stop using the word "recall" when telling the public about serious problems with implantable cardiac defibrillators and pacemakers, according to a report the Heart Rhythm Society released this fall.

The group's study, which the American College of Cardiology Foundation and the American Heart Assn. endorsed, also calls for the FDA and device makers to provide greater transparency and better postmarket monitoring.

The evaluation is an outgrowth of a policy conference the Heart Rhythm Society, an organization of cardiac electrophysiologists, held on the heels of a string of FDA heart-device recalls last year. One of these recalled devices, the Guidant Ventak Prizm 2 DR Model 1861 defibrillator, short-circuited and failed to send a lifesaving shock to Joshua Oukrup, a Minnesota 21-year-old with hypertrophic cardiomyopathy. The man died while bicycling.

The task force of 14 physicians and a nurse who authored the report concluded that the public would be served better by using terms such as "safety alert" or "safety advisory" instead of "recall" because, they said, many patients and some doctors mistakenly believe that a recalled heart device must be replaced.

The word "recall" is "inflammatory not just for patients but for physicians," said Dwight Reynolds, MD, Heart Rhythm Society president and chief of the cardiovascular section at the University of Oklahoma Health Sciences Center. "If you think about the Ford Pinto when you hear the word 'recall,' it's hard to sleep when you've got that in your chest."