Study finds high rate of defibrillator recalls

As the use of life-saving emergency defibrillators has proliferated over the last decade, so have recalls of the devices because of their potential to fail, according to data to be presented at a medical meeting. A study based on Food and Drug Administration records from the last 10 years found that about 164,000 emergency defibrillators – or about one out of every five units sold during the period – had been subject to an agency recall or alert.

During that period, the FDA also received 370 reports of deaths in which defibrillators or critical components malfunctioned during attempts to resuscitate patients in cardiac arrest, researchers reported. The study’s lead author of Beth Israel Deacones Medical Center in Boston said the growing use of emergency external defibrillators – portable devices like those used by paramedics and in hospitals that shock failed hearts back into normal rhythms – has resulted in thousands of saved lives.

But the data raised questions about the reliability of external defibrillators as well as how quickly users are learning about recalls.