Guidant Device Recall

GUIDANT - Reported Failures of Guidant Units

Reported Failures
Failure Reporting for Guidant Defibrillators and Pacemakers
Failure Reporting for Medtronic Defibrillators

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Guidant Defibrillator Recalls
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Guidant Reported Failures of Defective Defibrillators


Do you wish to report a failure for your Guidant defibrillator? For your Guidant Pacemaker? For your Medtronic Defibrilaltor? Do you want to learn which Guidant models have reported failures or are at risk for failure? Learn about the reported failures for Guidant and Medtronic defibrillator devices here.

Failure Reporting - All Guidant Models

Guidant Reported Failures
Failure Reporting for Guidant Defibrillators

 

Is there any good news?

Sort of. The good news is that the FDA has issed a recall of Guidant defibrillators and Guidant has agreed that this recall is necessary. The bad news is that there are over 100,000 units at risk in the United States alone.

But there have only recently been a larger number of "reported" failures because it was not clear until June 20, 2005 what was wrong with these units. And the only reason that it became public in June 2005 was that Guidant was concerned about the release of a truthful NY Times Report titled “Maker of Heart Device Kept Flaw From Doctors.”

Thus, only one day before the NY Times article, on May 23, 2005, Guidant sent doctors an “advisory” letter about the defibrillators. However, even then, Guidant refused to recall its units. So even during the next three weeks, there was less pressure on the public and the medical community to report adverse events.

Finally, in June and July, a series of recalls began. Now people are coming forward in larger numbers to report failures in their devices. In order to find out if your Guidant device is the subject of the recall, the best place to go is to Guidant's web site: Guidant defect lookup based on model and serial number.

The types of failures that are being reported for Guidant units fall into three categories. These are,

  • Internal short circuit
  • Memory error
  • Magnetic switch

Although the FDA tracks failures, the fact that these defective units were known of and sold for three years shows that the FDA reporting system is "broken" and that changes are needed to make it easier to report and more comprehensive for adverse reports to become public knowledge. Further, it is widely accepted that the FDA’s voluntary reporting system reflects only a small percentage (as little as 10%) of the actual number of events. Thus, the number of adverse events may be far greater than Guidant has revealed.


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Ask a Lawyer: Do I have a Guidant Defibrillator Recall Lawsuit?

Do I have a Guidant Defibrillator Recall Lawsuit? You may need a lawyer to represent you. Learn more by filling out the form below! Lawyers and experts ready to help you now.

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First Name:
Last Name:
E-mail Address:
Phone: () - ext.
Address:
City:
State:
Zipcode:
Age:
Date of Birth:

What complications have you had from the Guidant defibrillator implant?
For What recommendations have your doctors made about removing this device?
For Please list any relevant Surgeons, Hospitals, and Cardiologists who are treating or have treated you with respect to the Guidant implant. (Please include city & state)
Implant Date: What was the date you received your implant?
If removed, what was the date of REMOVAL of your implant?
Which manufacturer's device has been implanted? (please check all that apply)
GUIDANT
MEDTRONIC defibrillators
Which device(s) have been implanted? (see ID Card for Model #) (please check all that apply)
Ventak Prizm 2 DR (Model 1861), prior to April 16, 2002
Contak Renewal (Model H135), prior to Aug. 26, 2004
Contak Renewal 2 (Model H155), prior to Aug. 26, 2004
Ventak Prizm AVT
Vitality AVT
Renewal 3 AVT
Renewal 4 AVT
Medtronic Concerto
Unknown or Other
Additional Guidant Recall Lawsuit Information: Please be specific and tell us about your experience with the Guidant Defibrillator. Also enter any questions or comments in this space.
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