U.S. Sues Medtronic Over Defibrillators

SEATTLE (CN) - Federal prosecutors want Medtronic enjoined from making six models of Lifepak defibrillators and four types of Lifenet cardiac systems until it fixes the quality control problems in the devices.

Prosecutors claim Medtronic and its subsidiary, co-defendant Physio-Control, distributed defective and misbranded devices, failed to submit required reports to the FDA, failed to investigate complaints about the devices' failures, and that Medtronic and Physio-Control "are well aware that their practices violate the FDCA [U.S. Food, Drug, and Cosmetic Act] and applicable regulations".

Uncle Sam also sued Medtronic CEO William A. Hawkins and Physio-Control President Brian D. Webster.

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