Associated Press, "FDA gives heart implant recall highest warning -- not urging removal of Guidant devices; patients should contact doctors"
A malfunction in some of the Guidant Corp. defibrillators recalled last month could cause serious injury or death, the government said Friday [July 1, 2005] in classifying 20,000 of the devices as the most urgent type of recalls. The Food and Drug Administration is not urging that the recalled defibrillators be removed. But it used Friday's action to urge patients to contact their doctors to decide appropriate next steps. Guidant recalled a series of defibrillators last month. The new FDA action lists a portion of them as Class I recalls, the most serious type -- a move that may help doctors in deciding how aggressively to notify and treat their patients.