Endologix Inc. said it will voluntarily recall its Nellix System immediately to stop the device's unapproved use and will only sell it to pre-screened patients under current indications.
Nellix System is approved to treat abdominal aortic aneurysm, which refers to an enlarged area in the lower part of the body's major blood vessel, the aorta.
The Irvine, Calif.-based company said the device will only be made available to patients who are screened by a physician panel to ensure the product is used as intended.
The medical device maker said that data from its studies suggested that the device was being used for unapproved, or off-label, indications leading to poor outcomes.
The company is in contact with regulators on the recall and expects continued appropriate access to the device.