Guidant Defibrillator Recall
On June 17, 2005, Guidant Corporation, a medical device maker, recalled more than 50,000 of its cardiac defibrillators implanted in patients because of potential malfunctions in the devices.
Battery-powered defibrillators are used to shock an erratically beating heart back into normal rhythm. The devices typically are replaced about every five years.
According to Guidant, the devices have reportedly failed at least 45 times and have caused at least two deaths as recently as May 30.
The recall includes the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs. The company said about 63,000 of the devices had been implanted, with nearly 50,000 still in use.
On May 23, 2005, Guidant issued a safety advisory to physicians concerning its heart defibrillator, reportedly 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 for three years that the device contains a flaw that has caused a small number of defibrillators to short-circuit and stop working.
The Guidant Heart Device Flaw Explained
The short circuit in the defibrillator can occur when the device builds a charge to deliver the type of high-energy shock needed in emergency situations. In three cases, when doctors intentionally induced abnormal heart rhythms during routine checkups, the Guidant device failed to work, forcing doctors to rescue those patients by jolting them with the type of external defibrillator used in emergency rooms.
Guidant Issues Further Warning on its Pacemakers and Defibrillators on June 24, 2005
Guidant advised physicians to halt use of five models of cardiac defibrillators. Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter defibrillators, or ICDs. The Renewal 3 and 4 AVT models were also included in Guidant's June 17, 2005 recall.
Guidant said it 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 atrial tachyarrhythmias and can accelerate battery depletion.
The suspension affects 46,000 of these devices, Guidant said, without specifying how many have been surgically implanted in people's chests and how many may be on supply shelves. The Indianapolis-based company said it found four cases of an electrical failure that can prevent the devices from shocking an irregularly beating heart back into a normal rhythm, and a fifth is suspected. No injuries or deaths were reported.
Legal Rights of the Injured
The law in most states provides individuals with legal claims and the right to compensation for injuries they suffer as a result of a defective product or the negligence of another. The injured person may file a lawsuit seeking compensation for his or her pain and suffering, medical expenses, lost past and future wages and punitive damages.
Damages sought against manufacturers of an allegedly defective medical device typically include damages for:
- Physical pain and suffering, mental anguish and physical impairment;
- Medical expenses associated with the allegedly defective product; and
- Loss of earnings and/or earning capacity.
THINGS THE INSURANCE
COMPANY DOES NOT WANT YOU TO KNOW
If you or a loved one has suffered injury or death due to
a defective defibrillator in Baton Rouge, Gonzales or anywhere in
Louisiana, please e-mail or call
our Louisiana product liability attorneys at 877-884-1321
to schedule your free consultation.
