Medtronic Recall Earns FDA's Most Serious Rating

By Nick Malinowski

Law360, New York (April 22, 2010, 5:44 PM ET) -- 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...
To view the full article, take a free trial now.

Already a subscriber? Click here to login

You must correct or enter the following before you can submit this form:

All fields required

  5. Required

Only Law360 gives you:

Non-stop coverage of high-stakes litigation across 30 practices

Real-time tracking and reports on 10,000+ companies, firms and industries

Over 80,000 attorney profiles with neutral data collected from active lawsuits

Research tools to find cases, court documents, attorneys and companies

Customized feeds and alerts that can easily be shared with colleagues

In-depth expert analysis from high-profile attorneys at top firms

Access to our vault with over 75,000 original articles