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."