Disturbing uptick in defibrillator recalls
Most pacemakers and implantable cardioverter/defibrillators work as they should, though the number recalled each year is growing.
Two parallel trends capture the promise and perils of pacemakers and implantable cardioverter/defibrillators (ICDs):
The number of devices implanted, and the number of lives saved, grows steadily each year.
So does the number of devices that malfunction or are recalled.
The vast majority of pacemakers and ICDs do their jobs without a hitch. In the 2.6 million devices implanted between 1990 and 2002, just 17,323 (0.66%) malfunctions were confirmed, according to an exhaustive analysis of FDA data by Dr. William H. Maisel of Harvard-affiliated Beth Israel Deaconess Medical Center (see chart). These malfunctions accounted for 61 deaths, or two deaths for every 100,000 devices implanted.