According to news reports, several models of Guidant Cardioverter Defibrillators may have flaws that could cause them to short-circuit and malfunction and cause injury or death. Last month, Guidant disclosed that there were electrical problems with its Ventak Prizm 2 Defibrillators, of which approximately 24,000s have been implanted in persons worldwide. On Friday, June 17, Guidant announced a recall of the Ventak Prizm 2 and additional model ICD's. The Guidant recall includes:
- VENTAK PRIZM 2 DR (Model 1861) ICDs manufactured on or before April 16, 2002.
- CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) CRT-Ds manufactured on or before August 26, 2004.
- VENTAK PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT ICDs (All series numbers).
On June 24, 2005, Guidant issued an advisory about additional defibrillator devices including the following models:
- Contak Renewal 3 and 4
- Renewal 3 and 4 AVT
- Renewal RF
Guidant claims that it discovered the short circuiting defect in 2002 and changed the manufacturing of the devices that year to correct the defect. However, Guidant continued to sell the old defective devices without notifying doctors that improved ones were available. Defibrillators cost approximately $25,000 apiece. Guidant’s 2004 defibrillator sales totaled $1.8 billion, signaling that until recently, Guidant may have been more motivated by profits than by patient safety.
The manufacturer, Guidant Corporation, is headquartered in St. Paul Minnesota.
Guidant Cardioverter Defibrillators (ICD) are implanted devices that detect abnormal heart rhythms (ventricular arrhythmias) and shock the heart back to a normal rate. The devices consists of a pulse generator (a battery and electronic circuitry) connected to one or two insulated wires (leads). The pulse generator is usually implanted under the collarbone, just beneath the skin. The main lead is inserted into the lower right heart chamber (the right ventricle). A second lead may be placed in the upper right heart chamber (the right atrium).
If you or a loved one has been injured by a Guidant Defibrillator you may have valuable legal rights. We will evaluate your case for free.