Study suggests pacemaker and defibrillator recalls on the rise

As more heart patients receive pacemakers and implantable cardioverter-defibrillator (ICD) generators, more recalls are being issued for the devices, according to a study led by a Harvard Medical School instructor based at Brigham and Women’s Hospital in Boston. “Pacemakers and ICDs are two of the most remarkable medical and technological advances of the 20th century. However, while they are life-saving in many instances, they may occasionally malfunction and require recall by the U.S. Food and Drug Administration (FDA),” said lead study author William H. Maisel. “In our analysis, we found that pacemaker and ICD recalls and safety alerts occur frequently, affect many patients, and appear to be increasing in number and rate.” Hardware malfunctions and computer errors accounted for 95 percent of all recalls. While not every recalled device was defective, an estimated 1.3 million device checks and analyses and more than 36,000 device replacements resulted from FDA advisories and cost approximately $870 million between 1990 and 2000.