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U.S. Department of Health and Human Services

Medical Devices

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Ventak PRIZM 2 DR ICDs

Class 1 Recall
Date Recall Initiated:

June 29, 2005

Product:

Ventak PRIZM 2 DR Model 1861 Implantable Cardioverter Defibrillators (ICDs) manufactured on or before April 16, 2002

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 devices' 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 neaarby links.