FDA Issues Class I Recall Of Medtronic Defibrillators

Law360, New York (July 6, 2010, 4:49 PM EDT) -- The U.S. Food and Drug Administration is classifying the voluntary recall of Lifepak 20 and Lifepak 20e defibrillators manufactured by a Medtronic Inc. subsidiary as Class I, less than three months after the agency issued a similar recall of the company's Lifepak 15 defibrillators.

Physio-Control Inc. announced on Friday that the company had initiated a field correction of certain versions of the product manufactured prior to January 2009 due to the potential of the battery power failing during use.

“A failure on the power assembly can...
To view the full article, register now.