GUIDANT AND MEDTRONIC DEFIBRILLATORS

In June of 2005, Guidant Corporation recalled thousands of their Implantable Cardioverter Defibrillator (ICD) due to a manufacturing defect that may cause the device to short-circuit or malfunction. It is alleged that Guidant knew of the problems with their heart defibrillators and failed to publicly disclose the life-threatening defects until FDA intervention and public scrutiny.

These popular ICDs are implanted into patients with congestive heart failure, abnormally fast heart rhythms/ tachycardia or irregular heartbeats to shock their faltering heart. According to the American Heart Association, 64,000 implantable defibrillator operations are performed on U.S. patients each year. Approximately 24,000 defective Guidant ICDs have been implanted in U.S. patients.

The initial defibrillator in question was the Ventak Prizm 2DR, Model 1861, manufactured on or before April 16, 2002. However, Guidant has increased the recall to now include all of the following models:
VENTAK PRIZM 2 DR (Model 1861)
VENTAK PRIZM AVT
CONTAK RENEWAL (Model H135)
CONTAK RENEWAL 2 (Model H155)
VITALITY AVT
RENEWAL 3 AVT
RENEWAL 4 AVT

After further investigation by Guidant and the FDA, the FDA uncovered more reports of device failures and deaths linked to Guidant ICDs. To date, Guidant has recalled or issued warnings for over 80,000 heart defibrillators, including its best selling Contak Renewal 3.

Class I Guidant Recall: PRIZM 2 DR, CONTAK RENEWAL, CONTAK RENEWAL2

In a Class I recall, there is a reasonable probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death.

Class II Guidant Recall: VENTAK PRIZM AVT, VITALITY AVT, and RENEWAL AVT Devices, CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF Devices

In a Class II recall, the malfunctioning product may cause temporary or medically reversible adverse health consequences. These Guidant devices are said to be subject to a memory errors.

Accusations against Guidant

Currently Guidant faces over 100 individual and class action lawsuits related to its defibrillator and pacemaker products. Guidant may also face a civil lawsuit by the federal government for failure to disclose its product's potentially fatal defects. Medical professionals and legal professionals believe that Guidant withheld pertinent information about defibrillator malfunctions and mechanical design defects. It is alleged that Guidant learned of their ICDs life-threatening defects in 2002 but did not disclose this information to the public until 2005 while heavily marketing their products worldwide.

Guidant designs, manufactures, and distributes products focused on the treatment of cardiac arrhythmia, heart failure and coronary and peripheral disease. Guidant is pending acquisition by Boston Scientific Corp. for $27 million.

Medical professionals advise that if you have a Guidant defibrillator, talk to your doctor as soon as possible to find out more about your medical options.

If you have the device implanted, had the device replaced or plan to have it replaced, whether or not you suffered complications from at this time, you may be entitled to compensation.

Jul-11-06: FDA Affirms Physicians should conduct Follow-Up Exams of Patients.

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First Name: *

Last Name: *

Email Address: *

Phone Number: *

State: *

Describe your Case: *

Describe Damages you Suffered: *

Name of Implantee (if different):

Date of Birth:

Date of Death (if applicable):

Serial Number of unit (see ID card):

Date of Implant:

Surgeon's Name:

Surgeon's Phone Number:

Was the device removed?

Yes No

If yes, when:

If yes, where:

Where is the device now:

Which Guidant Cardiac Defibrillator was implanted:

Ventak Prizm AVT?

Yes No

Prizm 2 DR?

Yes No

Contak Renewal?

Yes No

Contak Renewal 2?

Yes No

Vitality AVT?

Yes No

Renewal 3 AVT?

Yes No

Renewal 4 AVT ICD?

Yes No

Don't Know

Yes No

If other, what is the name of the defibrillator that was used?

What medical condition caused or prompted the use of a defibrillator?

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