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.

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