Violation Tracker Individual Record

Company: 
ev3 Inc.
Current Parent Company: 
Medtronic
Penalty: 
$17,900,000
Year: 
2018
Date: 
December 4, 2018
Offense Group: 
safety-related offenses
Primary Offense: 
drug or medical equipment safety violation
Violation Description: 

Minnesota-based medical device manufacturer ev3 Inc. agreed to plead guilty to charges that it distributed an adulterated version of its neurovascular medical device, Onyx Liquid Embolic System. As part of the criminal resolution, ev3 agreed to pay a criminal fine of $11.9 million and will forfeit $6 million.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Justice Department Civil Division
Civil or Criminal Case: 
criminal
HQ Country of Parent: 
Ireland (reincorporated for tax reasons)
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
medical equipment and supplies
Specific Industry of Parent: 
medical devices
Source Notes: 
If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Parent company note: 
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.