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.
          Now listed as a Class 1 recall are three models: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.) The FDA said about 20,600 of these devices are still believed to be implanted; at least two patients have died.
          Listed as a lower-priority Class II recall Friday are the Guidant models Ventak Prizm AVT, Vitality AVT and Renewal AVT. A Class II recall means that any injury caused by a malfunction should be temporary or reversible.
          Also given a Class II priority are Guidant's newest models, the Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF brands. A magnetic switch may become stuck, inhibiting the ability to treat certain irregular heartbeats unless doctors fix it, also possible non-invasively. Four such malfunctions have been confirmed among about 46,000 implanted devices; a fifth is suspected, FDA said.
          Tones sounded by the device signal the malfunction; patients who hear those tones should go to the emergency room, the FDA said.

To learn more about the Guidant recall and defective and dangerous product lawsuits against Guidant, click here