High Rate of Heart Device Recalls

A study based on FDA records for the last 10 years found that 164,000 external defibrillators (one out of every five) were subject to recall or agency alert.  The data included 370 reports of deaths in which the defibrillator malfunctioned.  Actually, the number was much higher, 801 adverse-event reports associated with death, but the study only counted the cases in which an emergency worker confirmed the malfunction.  The recent problem facing the FDA on notifying users about deficiencies has become more complex since they are now being used at hotels, schools and homes (an increase in sales from 20,000 to 200,000).  If a loved one cannot be saved, check out the defibrillator.