Defective Guidant Pacemaker Recall
A Food and Drug Administration (FDA) classified Guidant pacemaker recall was issued for certain defibrillator models on June 17th, 2005. This most recent Guidant recall relates to both the Guidant implanted cardioverter defibrillator (ICD) and cardiac resynchronization therapy (CRT) devices. Although technically different, pacemakers and defibrillators are both devices responsible for regulating heart rate/rhythm control, leading consumers to use the term “Guidant pacemaker” interchangably on occasion.
Heart disease (cardiac arrest) is one of the leading causes of death for Americans, accounting for approximately 200,000 to 400,000 deaths each year. Cardiovascular medical devices, such as those designed and developed by Guidant, are used to treat patients suffering from heart rate/rhythm abnormalities (typically resulting from some type of heart trauma).
The Guidant devices are implanted in the chest area where they monitor heart function. Accelerated heart rate (tachycardia) can be controlled by such devices. When functioning properly, cardiovascular medical devices can provide significant aid to patients suffering from heart rate/rhythm abnormalities.
The Guidant Corporation is one of the world’s leading designers / developers of cardiovascular medical devices. Incorporated in 1994, Guidant Corporation has grown rapidly, housing more than 12,000 employees and generating more than $3.8 billion in revenue.
The Guidant Corporation specializes in the manufacture of a wide variety of cardiovascular medical devices, some of which include:
- Implantable cardioverter defibrillators (ICDs)
- Cardiac pacemakers
- Cardiac resynchronization therapy (CRT)
Guidant Medical Device Defects
Defective medical devices do not always warrant the issuing of a product recall. Defects are an unfortunate commonality for any manufacturer; however, recalls are warranted when a defect is judged to be present across a wide range of devices.
On September 12th, 2005, Guidant issued an advisory in regards to implanted Contact Renewal devices (models H135 and H155). This device had previously demonstrated a defect related to the deterioration of a wire insulator that surrounded a high voltage wire inside the device header. Deterioration of this wire can cause an electrical shortage of the device, inhibiting its ability to administer shock therapy treatments to the patient. The September 12th communication resulted from the discovery of a higher than expected failure rate for the H135 and H155 models (.72% to 1.83% failure rate). The defect was responsible for a significant amount of device failure, in addition to causing three deaths. Patients equipped with these devices are advised to consult their physician as to the best course of action regarding the defective product.
Guidant has been forced to issue various safety updates regarding potential malfunctions and possible recalls. Between June and September of 2005, Guidant issued five separate recalls for defective devices. The serious nature of the recalls led to the eventual purchase of Guidant by competitor Boston Scientific.
In April of 2007, Guidant issued a recall for approximately 73,000 ICD and CRT devices because of battery-shortage issues. The defect caused the rapid depletion of battery-life, reducing its capacity to three months or less as opposed to the intended two (+) years. The Guidant devices affected by the April recall include:
- Contak Renewal 3 HE CRT-Ds (H177 & H179)
- Contak Renewal 3 CRT-Ds (H170 & H175)
- Vitality 2 DR ICDs (T165)
- Vitality 2 VR ICDs (T175)
- Vitality AVT ICDs (A155)
- Vitality DS DR ICDs (T125)
- Vitality EL DR ICDs (T135)
As of yet, there have been no deaths or serious injuries reported as a result of the defects.
Guidant is required to immediately alert the FDA, doctors and the public at large of any defective products whenever such information becomes known to them. Failure to alert all appropriate parties in a timely manner further increases Guidant’s liability related to injuries caused by defects.
Defective Guidant Pacemakers – Lawsuits
Cardiovascular medical device manufacturers have a responsibility to ensure the safety and functionality of their product lines before they are sold commercially. Defects that result from manufacturer negligence may warrant legal action for those who have been injured through usage. Patients and loved ones who suffer injuries due to a defective Guidant pacemaker or other medical device may be eligible to receive compensation.
The law offices of Aylstock, Witkin, Kreis & Overholtz have a great deal of experience in litigation associated with personal injuries incurred as a result of defective medical devices like Guidant pacemakers. If you or a loved one has been injured by a defective medical device (Guidant pacemaker, ICD or CRT), the defective medical device lawyers of Aylstock, Witkin, Kreis & Overholtz are waiting to hear from you to discuss all your legal recourse options.