DEADLY CARDIAC DEFIBRILLATOR
On June 17, 2005, Guidant recalled more than 50,000
of its cardiac defibrillators implanted in patients
because of potential malfunctions in the devices.
The recall includes the Ventak Prizm 2 DR (model
1861), Contak Renewal (model H135) and Contak
Renewal 2 (model H155), Ventak Prizm AVT, Vitality
AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3
and 4 AVT and Renewal RF.
Guidant has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or a trail tachyarrhythmias and can accelerate battery depletion.
As of June 2005, Guidant was aware of 43 reports of device failures, and two patient deaths. Guidant has acknowledged that the actual rate of failure may even be higher than the reported rate and that the number of associated deaths may be under reported, since implantable cardiac-defibrillators are not routinely evaluated after death.
The recall came shortly after Guidant issued a safety advisory to physicians concerning its heart defibrillator, shortly after the company learned an article by the New York Times was being prepared. The New York Times reported that Guidant did not tell doctors or patients that it knew since 2002 it knew, that a small number of its defibrillators contained a flaw that caused them to short-circuit and stop working.
On July 1, 2005, the FDA classified the recall of
certain Guidant defibrillator models as a Class 1
recall, the most serious level of product recall.
If you or a loved one have been injured or killed
due to a faulty Heart Device you may be entitled to
the following types of monetary damage awards:
*Physical pain and suffering, mental anguish and
physical impairment;
*Medical expenses associated with the allegedly
defective product;
*Loss of earning and/or earning capacity;
*Punitive Damages
Contact the Raphaelson Law Firm immediately for a free case evaluation. There is no charge or obligation for our review of your case. Our lawyers have years of experience representing patients that have been injured by faulty or defective medical products.
