Flawed Device Places F.D.A. Under Scrutiny

Article Abstract:

Access Cardiosystems acknowledged defects in their Red Rooster III portable defibrillators, and recalled all 18,500 units they had produced over the last two years. The Food and Drug Administration inspected the company's factory and found no defects, but when more defibrillators malfunctioned, the agency did not repeat their inspection.

Marketing procedures, Usage, Powers and duties, Inspection, United States. Food and Drug Administration, Customer relations, Access CardioSystems

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Files Show Guidant Foresaw Some Risks

Article Abstract:

A Guidant Corp. internal report from 2002 shows that the company was aware of defects in its implantable defibrillators, but felt the failure rate was acceptable. Guidant did not notify doctors about the devices flaws until last spring.

Legal issues & crime, Legal/Government Regulation, Company legal issue, Cases, Records and correspondence, Cardiovascular instruments, Implanted, Cardiovascular implants

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Faulty Heart Devices Force Some Scary Decisions

Article Abstract:

Heart patients that have received a faulty Guidant Corp. defibrillator face the difficult decision of whether to leave it in and risk equipment failure or to take it out and risk another surgery.

Public affairs, Ethics, Care and treatment, Ethical aspects, Heart diseases

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