Recalls and Safety Alerts Involving Pacemakers and Implantable Cardioverter-Defibrillator Generators
Open Access
- 15 August 2001
- journal article
- research article
- Published by American Medical Association (AMA) in JAMA
- Vol. 286 (7) , 793-799
- https://doi.org/10.1001/jama.286.7.793
Abstract
Permanent pacemakers and implantable cardioverter-defibrillators (ICDs) are 2 of the most remarkable medical and technological advances of the 20th century. While these devices are life-saving in many instances, they may occasionally malfunction.1 The US Food and Drug Administration (FDA) is responsible for the safety and oversight of all medical devices in the United States. Weekly FDA Enforcement Reports are issued that include recalls and safety alerts (referred to collectively as advisories), a number of which have involved pacemakers and ICDs.Keywords
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