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On July 1, the FDA issued official classifications for recalled implantable cardioverter-defibrillators (ICDs) manufactured by Guidant Corporation (see http://www.fda.gov/bbs/topics/NEWS/2005/NEW01198.html). One group of devices has received a Class I recall; two other groups have received Class II recalls.
A Class I recall means that if a particular device malfunctions, there is “a reasonable probability” of serious adverse health consequences or death.
VENTAK PRIZM 2 DR, model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL, model H135, manufactured on or before August 26, 2004
CONTAK RENEWAL 2, model H155, manufactured on or before August 26, 2004
Guidant has determined that “these devices can develop an internal …