Guidant Defibrillator FAQ

Q: What is a defibrillator?

A: Defibrillator refers to surgical equipment implanted in patients who have a kind of heart ailment that results to a life-threatening heart arrhythmia, a medical condition characterized by an abnormal rhythm of the heart. This tool can bring an electrical shock to the heart to restore its normal heart rhythm.

Defibrillators are produced by Guidant Corporation which have been directed for recall recently. Then, in April 2006, Boston Scientific acquired the Guidant Corporation.

Q: Why were Guidant defibrillators recalled?

A: US Food and Drug Administration released a countrywide notification of recall in June 2005 for particular implantable defibrillators and cardiac resynchronization therapy defibrillators of Guidant. US FDA declared that particular devices were subjected to various failures, which might lead to their inability to bring an electrical shock during the episodes of arrhythmia.

In June 2006, Boston Scientific made another recall on some defibrillators. Boston/Guidant affirmed 5 reports of device malfunction among 27,200 patients all over the world who had these devices implanted.

Q: Which equipments were affected by the recall?

A: Guidant defibrillators that were affected by the recall notification in June 2005 were as follows:

• PRIZM 2 DR, Model 1861, produced on or before April 16, 2002
• CONTAK RENEWAL, Model H135, produced on or before August 26, 2004
• CONTAK RENEWAL 2, Model H135, produced on or before August 26, 2004

Boston Scientific declared another recall on the following defibrillators in June 2006:

• CONTAK RENEWAL TR and TR 2 cardiac resynchronization pacemakers
• VENTAK PRIZM 2, VITALITY, and VITALITY 2ICDs (implantable cardioverter defibrillators)
• Certain Insignia and Nexus pacemakers

Q: Was there any death reported as a result of defibrillator malfunctioning?

A: US FDA acquired reports of 2 deaths in June 2005, which were suspected to be linked with Guidant defibrillator malfunctioning.

Then in June 2006, Boston Scientific/Guidant report one malfunction, which happened during the implantation procedure. In 4 other cases, the patients needed device replacements where two of these cases, the patients became unconscious when the devices malfunctioned. However, there were no deaths reported.

Q: What should I do if I have Boston Scientific/Guidant defibrillator implanted?

A: It was in June 2005, US FDA suggested adhering to these steps if you are affected y a faulty defibrillator:

• Contact your physician to know if you have an affected product
• Keep your regular doctor appointments
• Call your doctor if you feel an electrical shock
• Contact your doctor immediately or the emergency room when there is audible sound, which might be a sign that the device you are using is damaged

In a recent recall, Boston Scientific sent letters to doctors and patients to give them warning and advise that patients must see their doctors right away.

Q: What should I do if I think I have been affected by a faulty defibrillator?

A: If you or any of your family members have been implanted with Guidant defibrillator and experience any uncommon medical condition, you should call your doctor right away. Then, you may find for an experienced lawyer to deliberate your options and safeguard your legal rights to remedy the injury you have sustained which was caused by Guidant defibrillator.

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