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# ev3 Agrees to Plead Guilty and Pay $18 Million
- URL: https://www.fdaweb.com/ev3-agrees-to-plead-guilty-and-pay-18-million/
- Published: 2018-12-04T12:00:00.000Z
- Updated: 2026-09-15T00:48:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142960

The U.S. Justice Department has [announced ](http://usfoodanddrugadministrationfda.pr-optout.com/Tracking.aspx?Data=HHL%3d%3d291%3b%26JDG%3c%3b5%3b182%3d%26SDG%3c90%3a.&RE=MC&RI=4380326&Preview=False&DistributionActionID=15378&Action=Follow+Link&ref=fdaweb.com)that medical device manufacturer ev3 has agreed to plead guilty to introducing an adulterated medical device into interstate commerce. The Onyx Liquid Embolic System is approved for use as a device that is surgically injected into blood vessels to block blood flow to arteriovenous malformations in the brain. From 2005 to 2009, company sales representatives “encouraged surgeons to use Onyx for unproven and potentially dangerous surgical uses outside the brain,” the government says. “The firm also set up a system of sales quotas and bonuses that incentivized sales representatives to sell the device for unapproved uses and trained the sales force on how to instruct physicians on unapproved uses of the device. The company, ev3, is expected to pay a criminal fine of $11.9 million and forfeit $6 million.”