Implantable Cardioverter Defibrillators (IDCs) are devices which can be implanted in the chests of heart patients to monitor and regulate irregular heartbeat (arrhythmia) by generating electrical pulses. Guidant Corp., a manufacturer of IDCs, admitted to failing to notify physicians and consumers when the company discovered defects in one of their defibrillator models. Defects included short-circuiting and memory errors. In 2005, the Federal Food and Drug Administration (FDA) issued a recall of 50,000 defective devices, some for potential malfunctioning that could result in serious injury or death. These recalls affected 11 of Guidant�s IDC models. Several class action lawsuits have been filed against the corporation and all federal cases have been consolidated under one judge.
Boston Scientific Recalls More Guidant Defibrillators
On June 26, 2006, Boston Scientific, the new parent corporation of Guidant Company, announced plans to recall six more models of defibrillators due to electrical problems. This news follows the recall of Guidant pacemakers and defibrillators related to similar problems in June 2005 .
Significant Health Risk To Guidant Patients
Boston Scientific stated that 27,000 patients with Guidant pacemakers and devices could potentially be affected by the electrical problems, which are related to faulty low-voltage capacitors. These capacitors store electrical charges for the devices, which are designed to regulate heart rhythm and rate in patients who suffer from heart failure, heart disease and other heart conditions.
The recall follows a “Dear Doctor Letter” dated June 23, 2006 entitled “”Urgent Medical Device Safety Information and Corrective Action.” The letter warned that specific lots of the Guidant devices could malfunction or underperform, leading to battery depletion or complete loss of function.
The products recalled are a subset of Guidant defibrillators. These include:
• Insignia pacemakers;
• Nexus pacemakers;
• Ventak Prizm 2 implantable defibrillators;
• Vitality implantable defibrillators;
• Vitality 2 implantable defibrillators; and
• Contact Renewal TR/TR2 cardiac resynchronization pacemakers.
• Fallout for Guidant and Boston Scientific
The news of Guidant’s latest recall is a blow to Boston Scientific, which has borne the brunt of its acquisition of Guidant in April 2006. Boston Scientific stock fell to a new low upon announcement of the recall, dropping $1.20 to its second consecutive 52-week low.
If You’ve Been Affected
Though the Guidant recall “Dear Doctor” letter does not recommend that patients with affected Guidant pacemakers and defibrillators receive surgery to remove the potentially defective devices, a Guidant spokesperson has indicated that patients with affected devices should consult with their physicians immediately.
If you have suffered from side effects due to defective or damaged Guidant pacemakers and Guidant defibrillators, consult an attorney experienced in defective medical products. Your Guidant lawyer can help you assess whether you have viable Guidant claim and can help you obtain the compensation you deserve for your medical bills, lost wages, pain and suffering, future medical care, and other damages.
Guidant Defibrillators Recalled
Guidant Failed to Disclose Known Flaws in its Defibrillators for Three Years. Guidant came under fire in the spring of 2005 after The New York Times reported that it failed to alert physicians and heart patients about a potential problem with the VENTAK PRIZM DR model defibrillator. The FDA issued a Class I recall of the following Guidant devices: CONTAK RENEWAL (Model H135) CONTAK RENEWAL 2 (Model H155) CONTAK RENEWAL 3 AVT (Models M150, M155) CONTAK RENEWAL 3 AVT HE (Models M157, M159) CONTAK RENEWAL 4 AVT (Model M170, M175) CONTAK RENEWAL 4 AVT HE (Models M177, M179) VENTAK PRIZM 2 DR (Model 1861) VENTAK PRIZM AVT (Model 1900) VITALITY AVT (Model A135, A155) In a Class II FDA, recall there is a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.