Cardiac Devices

Recalls, Safety Alerts For Pacemakers, Implantable Defibrillators Are On The Rise

Published in Medical Devices and Surgical Technology Week, September 9th, 2001

Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillators (ICDs) occur often and appear to be increasing, costing millions of dollars annually, according to an article in the August 15, 2001, issue of the Journal of the American Medical Association.

William H. Maisel, MD, MPH, and colleagues at the Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, studied weekly U.S. Food and Drug Administration (FDA) reports from January 1990 through December 2000 to identify the number of advisories that involved pacemaker or ICD generators in the United States (FDA advisories include both recalls and safety alerts). ...

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Source: Medical Devices and Surgical Technology Week (2001-09-09)

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