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 . 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.
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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.
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