Guidant Corp. Pacemakers
Class 1 Recall
|Date Recall Initiated:|
July 18, 2005
The following models of Guidant pacemakers, manufactured between November 25, 1997 and October 26, 2000:
|Use:||Pacemakers of this type are surgically implanted in persons with a heart disease affecting the heart’s ability to generate and conduct electrical impulses. These devices generate small electrical impulses that trigger the heartbeat.|
Guidant Corporation – CPI Division
4100 Hamline Ave. N.
|Reason for Recall:||A seal within the devices can leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. Other unexpected device behaviors are also possible. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death.|
|Public Contact:||Consumers with questions may contact Guidant Corporation at 1-866-GUIDANT (1-866-484-3268).|
|Advice to Users:|
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
|For additional information on this product recall, see the Guidant Corporation Web site at: http://bostonscientific.mediaroom.com/index.php?s=24913&item=22184, which includes a copy of the company’s notice sent to physicians (http://www.guidant.com/physician_communications/PDM.pdf), and the FDA press release located at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108465.htm|