Date Recall Initiated |
June 29, 2005 |
---|---|
Product: |
|
Use: |
These devices are surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). The devices deliver an electrical shock to the heart to restore normal heart rhythm. |
Recalling Firm: |
Guidant Corporation Cardiac Rhythm Management 4100 Hamline Ave. N. Saint Paul, Minnesota 55112-5700 |
Reason for Recall: |
A deterioration in a wire insulator could cause a short circuit, resulting in the device’s inability to deliver an electrical shock during episodes of arrhythmia (abnormal heart rhythm) -- which could lead to a serious, life-threatening event for a patient. |
Public Contact: |
Consumers with questions may contact Guidant Corporation at 1-866-GUIDANT (1-866-484-3268) |
FDA District: |
Minneapolis |
FDA Comment: |
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; the FDA press release; the FDA Public Health Notification; and the FDA Advice for Patients. |
Updated July 18, 2005
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