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FDA > CDRH > Medical Device Recalls > Class I Recall - CONTAK RENEWAL and CONTAK RENEWAL 2 CRT-Ds

Medical Device Recalls
Class I Recall: CONTAK RENEWAL and CONTAK RENEWAL 2 CRT-Ds

Date Recall
Initiated

June 29, 2005
Product:
  • CONTAK RENEWAL Model H135 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured on or before August 26, 2004; and
  • CONTAK RENEWAL 2 Model H155 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) manufactured on or before August 26, 2004.
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:
  • If you are not sure which model you have, or if you have other questions regarding your device, you should consult with your physician.
  • Continue to keep your normal doctor appointments.
  • If you feel a shock, contact your doctor as soon as possible.
  • If you or others hear "beeping" from your device, go immediately to your doctor or the emergency room.

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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