Guidant Device Recall

GUIDANT Lawsuit
Guidant recalling implantable pacemaker defibrillator
Device Wrongful death lawsuit problems

GUIDANT facing pacemaker death lawsuit problems and is recalling its implantable pacemaker defibrillator device due to wrongful death problems. Guidant implantable pacemaker lawsuit problems being handled by Monheit Law lawyers.

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Guidant recalling pacemaker/defibrillator: Lawsuit
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Guidant notified doctors this spring that a small number of the Guidant implantable pacemaker devices (Prizm 2 defibrillators) failed because of an electrical problem, which was fixed in mid-2002. Which pacemaker models are involved? Why did the implantable pacemaker device disclosure come so late? Many problems are going to haunt Guidant as the facts unfold about recalling its implantable pacemaker defibrillator device due to wrongful death lawsuit cases.

Guidant recalling pacemaker/defibrillator: Lawsuit


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Why is Guidant recalling its implantable pacemaker defibrillator device?


What defect problems are resulting in a lawsuit and why is Guidant recalling its devices?


Who is responsible for the defibrilattor recall?


What is being done about Guidant implantable pacemaker defibrillator device flaws?


What can you do about the Guidant recall?


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ALERT: Deaths Caused by Powerheart, Cardiovive, CardioLife, Recall, Cardiac Science Corporation AED Devices

 

GUIDANT Lawsuit: Guidant recalling implantable pacemaker defibrillator device due to wrongful death lawsuit problems

 

There is a large controversy brewing regarding Guidant's handling of information (or lack of handling, or better yet lack of disclosure,) about a number implantable defibrillator (and icd pacemaker) models. What started out as one, became seven, became now eleven models of defibrillators and half a dozen or so pacemaker models now said to be at risk.

The company said it notified government regulators. But did they really? Was full disclosure made about the problem/flaw? It is beginning to appear from various Guidant lawsuit allegations, that in filings made with the FDA, rather that disclose a defect, Guidant attempted what some call a silent recall -- simply saying that they were making "enhancements" or "improvements" to a perfectly good device. Instead of coming out and disclosing the problems with its implantable pacemaker defibrillator, Guidant kept the information about wrongful deaths as a "trade secret." In reality, Guidant did not alert doctors until three years after the problem was apparently fixed.

The forms that get filed with the FDA are called 501(k) and PMA (Pre-Market Approval) forms. Lawyers for the plaintiffs (injured patients and those walking around with defective devices) as well as those that had to undergo an otherwise unnecessary surgery for removal and replacement, are studying the filings that Guidant made with the FDA. Plaintiffs intend to show that Guidant failed to show what it knew about the defects and that it did not comply with its duties under 501(k) and/or the PMA process.

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First Name:
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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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