Medtronic Recall Earns FDA's Most Serious Rating

Law360, New York (April 22, 2010, 5:44 PM EDT) -- The U.S. Food and Drug Administration has classified the voluntary recall of Lifepak 15 defibrillators manufactured by a Medtronic Inc. subsidiary as Class I.

Physio-Control Inc. launched a voluntary correction of versions of the product manufactured between March and December of 2009 in March of this year.

According to the FDA, the defibrillators are designed for use by trained medical personnel in emergency care settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest.

There is a potential for the device to unexpectedly...
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