Date Recall |
July 18, 2005 |
Product: |
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. |
Recalling Firm: |
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). |
FDA District: |
Minneapolis |
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://www.guidant.com/news/500/web_release/nr_000558.shtml, 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/bbs/topics/NEWS/2005/NEW01210.html
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Updated July 27, 2005
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