Boston Scientific suspends defibrillator sales - Yahoo! News

March 15, 2010 by RecallAware
Filed under: Health 

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Boston Scientific suspends defibrillator sales - Yahoo! News
WASHINGTON – Medical device maker Boston Scientific said Monday it is suspending sales of its heart-shocking defibrillator implants after failing to alert regulators to changes in manufacturing of the top-selling devices.

The company said it uncovered two production changes that were not cleared with the Food and Drug Administration. Medical device makers are required to alert regulators to significant changes in life-sustaining devices like defibrillators, which help correct irregular heart beats.

The Natick, Mass.-based company said it will retrieve all the affected devices from suppliers and hospitals.


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