Should FDA Drop the Term "Recall" For "Safety Alert"

Lee Coleman

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Doctors are pushing the FDA to use the term 'safety alert' instead of 'recall' to warn about pacemakers and defibrillators. Citing a loss of public confidence in the safety of implantable devices. The number of implanted defibrillators in the U.S. is down 8 percent in the last 12 months according to the Prudential Equity Group. The slump is blamed on a series of recalls on several pacemakers and defibrillators last year.

"The most controversial case involved Guidant Corp.'s Prizm defibrillators. Guidant, since acquired by Boston Scientific, fixed the problem in 2002 but did not inform patients and physicians until after the 2005 death of a patient with one of the devices."