6/27/06 – New recall of 50,000 additional Guidant pacemaker and defibrillator heart devices
On June 23, 2006 a letter was sent to physicians warning of malfunction defects in nearly 50,000 additional models of Guidant pacemakers and defibrillators. Over 27,000 of the recalled heart devices have already been implanted in patients.
The recall was issued for certain models of Insignia and Nexus brand pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality, and Vitality 2 cardioverter defibrillators. The devices were manufactured by Guidant Cardiac Rhythm Management, which is now owned by Boston Scientific Company. The recall of these additional models of Guidant pacemakers and defibrillators comes approximately one year after a June 2005 recall of several different model heart devices.
As a result of the prior June 2005 recalls of Guidant heart devices, it has been estimated that the manufacturer faces nearly 1,700 lawsuits. The announcement of this latest recall comes right before the anticipated start of the first trial over a recalled Guidant defibrillator in Texas. The trial was originally scheduled to begin in April 2006, but was postponed until July 2006.
PACEMAKER AND DEFIBRILLATOR MALFUNCTIONS
Physicians only recommend that a heart device be implanted if the safety features they offer to the patient outweigh the risks associated with the surgical procedure necessary to install the pacemaker or defibrillators. Pacemakers operate by sending electronic pulses to the heart to correct a slow heart beat. Defibrillators operate by shocking the heart into a normal patter when it is beating too fast.
The recalled models of Boston Scientific / Guidant pacemakers and defibrillators were shown to be defective. As a result, there may be intermittent or permanent loss of function for the heart device, or an early battery depletion. This defect was determined to have been caused by a defective capacitator.
It has been recommended that any patient with one of the recalled pacemakers or defibrillators schedule an appointment with the doctor who surgically implanted the device. The risks associated with removing or replacing the heart device will be weighed against the risks of leaving the defective and potentially dangerous device in. Depending on the medical condition of the patient, some experts will recommend leaving the device in even though it has a known defect which could cause failure.
POTENTIAL FUTURE RECALLS OF OTHER DEVICES
The Boston Scientific CEO acknowledged that the defective capacitator should have been caught before the product was sold to the public. However, as a result of the manufacturers failure to provide a safe product, nearly 30,000 defective heart devices were implanted into patients. These patients can not rely on the pacemaker or defibrillator serving the purpose it was initially implanted for.
During the announcement, the manufacturer also indicated that they anticipate further recalls of other models of heart devices in the future. However, limited information was provided to warn individuals with different models which devices may be affected by future recalls.
WHAT TO DO IF YOU HAVE A GUIDANT PACEMAKER OR DEFIBRILLATOR
If you, a friend or family member have an implanted pacemaker or defibrillator which was manufactured by Guidant (now owned by Boston Scientific), you should request an immediate consultation with a member of our legal team. Request a free consultation to determine if your device has been recalled. In addition, if your device has not been recalled, we can provide future alerts if other models of pacemakers or defibrillators are recalled.
Lawsuits are being investigated and filed against the manufacturers of several pacemakers and defibrillators to pursue financial compensation for those who had a defective heart device implanted. The lawyers of Saiontz and Kirk have experience handling legal claims for defective products and can protect your legal rights.
