Star Tribune (Indianapolis), "FDA gives Guidant recall urgency"

          The Food and Drug Administration said late Friday it has given a pacemaker safety advisory issued last week by Guidant Corp. its most serious classification as a product recall.
          The federal regulatory agency classified Guidant's action on nine models of pacemakers as a Class I recall, meaning the FDA has decided there is reasonable probability that if the devices malfunction it could result in "serious adverse health consequences or death."
          About 28,000 of the affected models are implanted in patients worldwide. Indianapolis-based Guidant said it had received reports that 69 pacemakers have malfunctioned because a seal within the device may leak, causing the circuitry to fail.
          On 20 occasions, one of the pacemakers failed to properly pace the heart, causing five people to pass out. Two additional reports involved patients who developed heart failure because the pacemaker was working too rapidly. One of these patients died, although it is unknown whether the device directly caused the death.
          Guidant, whose cardiac rhythm management division is based in Arden Hills, has now recalled more than 110,000 implantable cardiac defibrillators (ICDs) and pacemakers since late May. That's when news surfaced that the company had failed to notify doctors about a potential malfunction in one of its popular heart-shocking devices.