Vasca defends LifeSite device as lawsuit filed
This article was originally published in Clinica
Executive Summary
Vasca, which has developed the LifeSite haemodialysis access system, has said it plans to strenuously defend against claims raised in a lawsuit filed in California on behalf of a patient. The claims relate to the company's sale of the product as well as issues raised in an FDA warning letter sent in November 2001, the Tewksbury, Massachusetts-based company said. Since the device went on sale, the letter states, there have been at least 129 complaints reported to the company involving death or serious injury.